Principal Investigator for St. Petersburg area for Sanofi Winthrop Clinical Trial DRI2643 a Multicenter, Randomized, Parallel, Double Blind, Dose Ranging Study of Subcutaneous XXXX with an Assessor Blind, Comparative Control Group of Subcutaneous XXXX in the Prevention of Deep Vein Thrombosis after Elective Total Hip Replacement -1997
Principal Investigator for St. Petersburg area for Sanofi Clinical Trial EFC2442 A Multicenter, Multinational, Randomized, Double-blind Comparison of Subcutaneous XXXX with XXXX in the Prevention of Deep Vein Thrombosis and Symptomatic Pulmonary Embolism after Elective Hip Replacement -1998/1999
Principal Investigator for St. Petersburg area for Organon Clinical Trial Phase III Pentasaccharide Program for DVT Prophylaxis. A Multicenter, Multinational, Randomized, Double-blind Comparison of Subcutaneous XXXX with Subcutaneous XXXX in the Prevention of Deep Vein Thrombosis and Symptomatic Pulmonary Embolism in Subjects Undergoing Total Knee Replacement Surgery -1998/1999
Biomechanical Evaluation of a Hip Screw System with Retractable Tangs, with Donna Wheeler, PhD, University of Florida, Department of Orthopaedics, Gainesville, FL -1999
Biomechanical Comparative Analysis of an Unstable 4-Part Intertrochanteric Fracture Fixed by Two Compressive Hip Fixation Devices, University of Miami Orthopedic Biomechanical Lab, Miami Beach FL, May 2000 with Edward L. Milne Technical Director and Loren L. Latté, Director
Principal Investigator for St. Petersburg area for Orthologic Clinical Trial #OL10-99-01, A Prospective, Double-Blind, Randomized, Placebo-Controlled Phase I/II to Evaluate the Safety of XXXX and the Effect of XXXX on the Rate of Healing in Distal Radius Fractures -2000
Principal Investigator for St. Petersburg area for Searle/Pfizer Clinical Protocol for Successive XXXX Efficacy and Safety Studies. A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel Group Study in the U.S. to Compare the Efficacy and Tolerability of XXXX vs. Ibuprofen in Ankle Sprains (SUCCESS-IIA) IND #48,395 -1999 - 2000
Principal Investigator for St. Petersburg area for Astra Zeneca Protocol 237, A Randomized, Double Blind, Comparative Study of XXXX and XXXX for the Prevention of Venous Thromboembolism Following Total Hip Arthroplasty. -2000 - 2001
Consultant for National Institutes of Health Phase I Study Entitled: High Toughness High Impact Resistant Hip Implants. -2001
Principal Investigator for St. Petersburg area for Astra Zeneca Protocol 290, [EXULT] KNEE: Optimization of Dose (Study A) and Confirmation of Safety and Efficacy (Study B) of XXXX (Oral Direct Thrombin Inhibitor) Compared to XXXX (XXXX) for the Prevention of Venous Thromboembolism Following Total Knee Arthroplasty (TKA) -2001
Principal Investigator for St. Petersburg area for Glaxo Smith Kline Protocol SB424323 for Thromboembolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of XXXX in the Extended Prophylaxis Following Total Hip Arthroplasty -2001 - 2002
Principal Investigator for St. Petersburg area for Pharmacia Corporation Protocol 524E-CVD-0042-029 Thromboprophylaxis with Low Molecular Weight XXXX vs. XXXX in Patients Undergoing Primary Total Knee Replacement A Multi-center, Prospective, Randomized, Open-Label Study. -2001 - 2002
Principal Investigator for St. Petersburg area for Amgen, Inc. Protocol #20010117 A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) XXXX XXXX in Subjects Undergoing Preoperative Autologous Blood Donation (PAD) Before Elective Revision Total Hip Replacement or Bilateral Knee Replacement Surgery -2001 - 2002
Principal Investigator for St. Petersburg area for Merck Protocol 061-00/COX523. A randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of XXXX 90 mg qd vs. XXXX 50 mg tid in Patients with Osteoarthritis -2002
Principal Investigator for St. Petersburg area for Amgen, Inc. Protocol #20010181 An Open label, Parallel-Group Study to Assess Safety in Subjects Receiving a Single-Subcutaneous (SC) Dose of XXXX XXXX or Undergoing Preoperative Autologous Donation (PAD) Before Elective Noncardiac, Nonvascular Surgery -2002
Principal Investigator for St. Petersburg area for Orthologic Clinical Trial #OL09-01-03, A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of XXXX on the Rate of Healing in Distal Radius Fractures -2002
Principal Investigator for Merck, Inc., Protocol 072-00 A Randomized, Double-Blind Multicenter Study to Evaluate the Tolerability and Effectiveness of XXXX 90 mg Q.D. Versus XXXX XXXX 75 mg B.I.D. in Patients with Rheumatoid Arthritis -2003
Principal Investigator for St. Petersburg area for PRA/Organon/Sanofi/Synthelabo Protocol L8518 “Flexibility in Administration of Arixtra for Prevention of Symptomatic Venous Thromboembolism in Orthopaedic Surgery” -2003
Principal Investigator for St. Petersburg area for Ortho Biotech, An Open-Label Randomized, Parallel-Group Study to Confirm the Safety and Efficiency of XXXX (XXXX) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major Spinal Surgery -2003
MO3-644 Phase III, Randomized, Double-Blind, Fixed Dose, Parallel-Group, Comparison of Controlled-Release XXXXXXXX (XXX) vs. Placebo in Subjects with Osteoarthritis -2003
Principal Investigator for St. Petersburg area for Clinical Trial OL10-01-01. A Prospective, Randomized, Controlled Phase I/II Study to Evaluate the Safety and Efficiency of XXXX on Bone Healing in Lumbar Spinal Fusion -2003
Principal Investigator for St. Petersburg Area for Clinical Trial 10945. Oral direct factor XXXX inhibitor XXXX in the prevention of VTE inpatient undergoing total knee replacement -2003
Principal Investigator for St. Petersburg area for Clinical trial ABT713 A Phase III, Randomized, Double-Blind, Fixed-dose Parallel-Group Comparison of Controlled-Release XXXXXXX vs. Placebo I Subjects with Osteoarthritis -2004
Principal Investigator for St. Petersburg area for Clinical TrialA3471109. A Multicenter, Double-Blind, Placebo-Controlled Randomized study of the Analgesic Efficacy and Safety of XXXX 20mg QD and XXXX 20mg BID. Compared to Placebo Over Multiple Days for Management of Acute Postsurgical Pain in Patients Undergoing Anterior Cruciate Ligament Reconstruction -2004
Principal Investigator for St. Petersburg area for Clinical TrialOL10-01-01 A Prospective, Randomized, Controlled Phase I/II Study to Evaluate the Safety and Efficacy of XXXX on Bone Healing in Lumbar Spinal Fusion -2004
#CV185-010 A Phase II Randomized, Double-Blinded (XXXX)and XXXX), Active-Controlled (XXXX and XXXX),Parallel-Arm, Dose-Response Study of the Oral Factor XaInhibitor BMS-562247 in Subjects undergoing Elective Total Knee Replacement Surgery -2004
#OL-Adrfx-03 A Double Blind, Randomized, Placebo-controlled Phase IIb Study to Establish the Effective Dose Range and to Evaluate the Safety of XXXX in Adult Subjects with a Fractured Distal Radius -2004.
#3100N7-109-US A Phase I, Dose Escalating, Open Label, Safety and Feasibility Study of Recombinant Human Bone XXXXXXXX (XXXX) Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Femoral Diaphyseal Fractures Treated with Reamed Statically Locked Antegrade or Retrograde Intramedullary (IM0 Nail Fixation -2004
#1160.24 A Phase III Randomized, Parallel-Group, Double-Blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 followed by150mg Day 2- Completion, and 110 mg Day 1 Followed by 22mg Day 2Completion) of XXXX XXXX Administered Orally (Capsules), Compared to XXXX 30mg Twice a Day Subcutaneous For 12-15 Days, in Prevention of Venous Thrombolism in Patients with Primary Elective Total Knee Replacement Surgery (Re-Mobilize) -2004
DU176b-PRT007 A Phase IIa, Multi-Center, Multi-National, Open-Label, Dose Ranging Study of the Efficacy, Safety, and Toler-Ability of Oral XXXX Administered Once to Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty -2004.
A Multi-Center Double-Blind, Placebo-Controlled Randomized Study of XXXX 200mg BID, XXXX 300mg BID, and XXXX 400mg BID in the Treatment of Chronic Low Back Pain -2004
A Multicenter, Double-Blind, Placebo-Controlled, Randomized Study of the Analgesic Efficacy and Safety of XXXX 20mg QDand XXXX 20BID Compared to Placebo Over Multiple Days for Management of Acute Postsurgical Pain in Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction -2004
BAY a 0128/11694: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of XXXX on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery -2004
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of XXXX, XXXX in Subjects with Closed Fracture of the Tibial Shaft -2005
A 13 Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Trial of XXXX(XXXX) 100mg O.D, in Patients with Primary Hip Osteoarthritis using XXXX (200mg O.D.) as a Positive Control - 2005
A Multi-Center, Randomized, Placebo-Controlled, Phase III Efficacy and Safety Study of XXXX in Patients with Moderate to Severe Chronic Pain due to Osteoarthritis of the Hip or Knee
Protocol: 3040 An Open-Label, 12 Month Study to Evaluate the Safety, Tolerability, and Efficacy of XXXX XXXXXXXX for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Noncancerous Pain -2005
SK SB767905/012: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of XXXX 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain -2005
GSK SB767905/014: A Randomized, Double-Blind, Placebo- Controlled, Multicenter Phase III Study to Evaluate the Long-Term Safety of XXXX 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer Pain -2005
GSK ITI101711: A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of XXXX in the Prevention of Venous Thromboembolism following Total Knee Replacement Surgery -2005
Principal Investigator for Protocol 17CL228, A Phase II, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group Study of XXXX for the Prevention or Reduction of Opioid-Induced Gastrointestinal Side Effects in Subjects Undergoing Ambulatory Shoulder Surgery -2006
Principal Investigator for Protocol HM2006001, Multi-Center XXXX Skin Irritation/Sensitization Pilot Study in Non-Opioid-Naïve Patients -2006
Principal Investigator for Protocol M04-697, A Phase III, Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy of Extended Release XXXX/XXXX Tablets XXXX to Placebo in Subjects with Osteoarthritis -2006
Principal Investigator for Protocol A55710/1038, A Phase IIb, Randomized, Multicenter, Dose-Ranging Study Assessing the Safety and Efficacy of XXXX in the Prevention of Venous Thromboembolic Events (VTE) in Subjects Undergoing an Elective, Unilateral Total Knee Replacement -2006
Principal Investigator for Protocol 3100N7-210-WW, A Phase II/III Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP2)/Calcium Phosphate Matrix (CPM) in closed Diaphyseal Tibial Fractures -2006
Principal Investigator for Protocol 3100N7-211-WW, A Phase II, Multicenter, Single-Blind, Randomized, Stratified, Standard of Care Controlled, Feasibility and Safety Study of rhBMP-2-CPM as an Adjuvant Therapy for Fractures of the Proximal Femur -2006
Principal Investigator for Protocol 3100N7-212-WW, A Phase II, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus -2006
Principal Investigator for Protocol 11355, Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE; a controlled, double-blind, randomized study of XXXX in the prevention of VTE in subjects undergoing elective total knee replacement -2006
Principal Investigator for Protocol A3241008-1013, A One-Year Follow-up Assessment of Subjects who Participated in Protocol A3241002 -2006
Principal Investigator for Protocol SMI05002, Survey to assess the prevalence, characteristics and impact of breakthrough pain in chronic pain patients with and without cancer managed by clinicians who are not pain specialists -2006
Principal Investigator for Protocol DU176b-PRT011, A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose Study of XXX Compared to XXX in Patients Undergoing Elective Unilateral Total Hip Replacement -2006
Principal Investigator for Protocol C25608/3040/BP/US, An Open-Label, 12-month Study to Evaluate the Safety, Tolerability, and Efficacy or XXXX XXXXXXXX for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Noncancerous Pain - 6 month extension study -2006
Principal Investigator for Protocol 2005-01D, A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of XXXXX for Treatment of Painful Osteoarthritis of the Knee, with an Open-Label Safety Extension, 2006
Principal Investigator for Protocol 2006-02, A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of XXXXX for Treatment of Osteoarthritis (OA) of the First Carpometacarpal (CMC) Joint
A3191331, Gastrointestinal (GI) Randomized event and safety open label NSAID study (GI-REASONS) A randomized, open-label, blinded-endpoint, parallel-group trial of GI safety of XXXX compared with non-selective nonsteroidal anti-inflammatory drugs (NSAIDS) in osteoarthritis patients. -2007
Principal Investigator for Protocol 150-CL-033, A Phase IIb, Double Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of XXXX In Subjects Undergoing Primary Elective Knee
Arthroplasty -2008
Protocol WA2049A/ACT3985g, A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of XXXX Compared Placebo in Patients with Active Rheumatoid Arthritis Continuing Methotrexate Treatment
Protocol WA20496/ACT4394g, A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of XXXX Given as a Single Infusion of Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Protocol KF5503/16: R331333-PAI-3014, A Randomized Withdrawal, Active and Placebo-Controlled, Double-Blind, Multicenter Phase III Trial Assessing Safety and Efficacy of Oral XXXX in Subjects with Moderate to Severe Chronic Malignant Tumor-Related Pain -2007
Principal Investigator Protocol NMT 1077-301, A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release XXXX Compared to Placebo in Patients with Chronic Low Back Pain -2008
Principal Investigator Protocol NMT 1077-302, A Phase III, Flexible-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release XXXX Compared to Placebo in Patients with Osteoarthritis Pain -2007
Protocol C0407 Multicenter, Open Label Extension Study of 8 mg XXXX in Subjects who completed Protocols C0405 or C0406 for Symptomatic Gout -2007
Protocol 01-06-TL-OPIMET-008, A Phase IIIb, Double-Blind, Randomized Study to Determine the Efficacy and Safety of XXXX and XXXX Fixed-Dose Combination Therapy Compared to XXXX and to XXXX in the Treatment of Subjects with Type 2 Diabetes -2007
Principal Investigator Protocol TAK-442_201, A Phase II, Randomized, Active Comparator-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of XXXX in Subjects Undergoing Total Knee Replacement -2007
Principal Investigator Protocol 11355 BAYER RECORD 4 Study: Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE; a Controlled, Double-Blind, Randomized Study of XXXX in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement -2006
Protocol NU281, Effects of the Consumption of Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults -2008
Principal Investigator Protocol 150-CL-033 A Phase IIb, Double-Blind, Double-Dummy, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of XXXX in Subjects Undergoing Primary Elective Knee Arthroplasty -2007
Sub-Investigator Protocol 150-CL-033, A Phase IIb, Double-Blind, Double-Dummy, Randomized, Parallel group Study to Evaluate the Safety and Efficacy of Twice Daily Dosing and Once Daily Dosing of XXXX in Subjects Undergoing Primary Elective Knee Arthroplasty -2007
Principal Investigator Protocol 150-CL-040, A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare XXXX bid and qd Doses and XXXX for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery -2009
Principal Investigator Protocol A4091011, A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Analgesic Efficacy and Safety of XXXX in Patients with Osteoarthritis of the Knee -2008
Principal Investigator Protocol A4091012, A Phase III, Randomized, Double-Blind, Multidose, Active and Placebo Controlled, Multicenter, Parallel Group Study of the Analgesic Effects of XXXX in Adult Patients with Chronic Low Back Pain -2009
Principal Investigator Protocol A4091014, A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study of the Analgesic Efficacy and Safety of XXXX in Patients with Osteoarthritis of the Hip -2008
Principal Investigator Protocol A4091016, A Phase III, Multicenter, Randomized, Long Term Study of the Safety of XXXX in Patients with Osteoarthritis of the Knee of Hip -2009
Principal Investigator Protocol A4091025, A Phase III, Multicenter, Randomized, Double-Blind, Non-steroidal Anti-inflammatory Drug (XXXX)-Controlled Study of the Long Term Analgesic Efficacy and Safety of XXXX in Patients with Osteoarthritis of the Knee or Hip -2009
Principal Investigator Protocol A4091039, A Phase III, Randomized Double-Blind, Multidose, Active Controlled, Multicenter, Parallel Group Study of the Analgesic Effects of XXXX in Patients with Osteoarthritis of the Hip or Knee -2009
Principal Investigator Protocol EFC10571 (SAVE-KNEE), A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of XXXX with XXXX for the Prevention of Venus Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery -2009
Principal Investigator Protocol A4091040, A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Long-Term Safety Study of XXXX in Patients with Osteoarthritis of the Knee or Hip
Principal Investigator Protocol EFC10342 (SAVE-HIP), A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 with Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery -2009
Sub-Investigator Protocol A4091003, A Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Study of XXXX as Add-On Therapy to Opioid Medication in Patients with Pain Due To Bone Metastases -2009
Sub-Investigator Protocol A4091029, A Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Efficacy and Safety Study of XXXX as Add-On Therapy to Opioid Medication In Patients with Pain Due To Bone Metastases -2009
Principal Investigator Protocol ACT11308, A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of a Single Injection of XXXX on Reduction of Pain From Vertebral Fracture Associated with Osteoporosis -2009
Principal Investigator Protocol ACT11286, A Randomized, Double-Blind, Placebo-Controlled Study of the Effect of a Single Injection of XXXX on Reduction of Pain from Chronic Pancreatitis -2009
Principal Investigator Protocol A4091026, A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of XXXX on Peripheral Nerve Function in Patients with Osteoarthritis -2010
Sub-Investigator Protocol SP904, A Multicenter, Open-label Extension Trial to Asses the Long-term Use of XXXX and Safety of XXXX and Adjunctive Therapy in Subjects with Partial-onset Seizures -2010
Sub-Investigator Protocol SP902, A Historical-controlled, Multicenter, Double-Blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to XXXX Monotherapy in Subjects with Partial-onset Seizures -2010
Principal Investigator Protocol A4091040, A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Long-Term Safety Study of XXXX in Patients with Osteoarthritis of the Knee or Hip -2010
Principal Investigator Protocol INCB 18424-351, A randomized, double-blind, placebo controlled study of the XXXX inhibitor XXXX tablets administrated orally to subjects with primary myelofibrosis (PMF) , post Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential ThrombocythemiaMyelofibrosis (PET-MF) -2010
Principal Investigator Protocol 102295, A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of XXXX in Pediatric Migraineurs for the Treatment of Migraine with or without Aura -2010
Principal Investigator Protocol 0462-082-00, A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of XXXX for the Acute Treatment of Migraine in Children and Adolescents -2010
Sub-Investigator Protocol CV185068, A Phase III, Randomized, Double Blind, Evaluation of the Safety and Efficacy of Apixaban in Subjects with a Recent Acute Coronary Syndrome
Sub-Investigator Protocol ALO-01-10-4033, A Multi-center, Primary Care-Based, Open-Label, Study to Assess the Success of Converting Opioid Experienced Patients, with Chronic, Moderate to Severe pain to EMBEDA™ Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse And Diversion -2010
Sub-Investigator Protocol 1218.75, A Phase IIIb, 24 week, Randomized, placebo-controlled, double-blinded, efficacy and safety study of XXXX in Black/African American patients With type 2 diabetes with a MTT sub-study -2010
Sub-Investigator Protocol SMR/0211OBD-1033, A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of XXXX in Subjects with Opioid-induced Bowel Dysfunction
Sub-Investigator Protocol WEL-A-U306 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol® as Add-On to XXXX Therapy For Type 2 Diabetes Mellitus -2010
Principal Investigator Protocol 09-OA-002 A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof of Concept, Dose Finding Study of Intraarticular Bone Morphogenetic Protein (XXX) in Subjects with Osteoarthritis (OA) of the Knee -2010
Sub-Investigator Protocol H9B-MC-BCDM A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of XXXX in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response To Methotrexate Therapy -2011
Sub-Investigator Protocol H9B MC BCDO, A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Safety and Efficacy of XXXX in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy -2011
Sub-Investigator Protocol H9B MC BCDP, A Phase IIIb, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy Of XXXX in Patients with Rheumatoid Arthritis (RA) -2011
Sub-Investigator Protocol H9B MC BCDV, A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of XXXX in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had Inadequate Response To one or more TNF-α Inhibitors -2011
Principal Investigator 10-OA-004, An Open Label, Safety ExtensionStudy of Repeat Dosing with XXXX in Subjects with Osteoarthritis (OA) of the Knee
Sub-Investigator Protocol 1218.75, A Phase IIIb, 24-week, randomized, placebo-controlled, double-blinded, efficacy andsafety study of XXXX in Black/African American patientswith type 2 diabetes with a MTT sub-study
Sub-Investigator Protocol TZP-101-CL-P008, A Multicenter,Randomized, Double-Blind, Placebo-Controlled Study to Evaluatethe Efficacy and Safety of Intravenous (IV) XXXX Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI)Motility in Subjects Who Have Undergone Partial Bowel Resection
Sub-Investigator Protocol RAS-RLS, Safety and Efficacy of XXXX in Restless Leg Syndrome
Sub-Investigator Protocol AS001, A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled study to evaluateefficacy and safety of XXXX in subjects with active axialspondyloarthritis (axial spa)
Sub-Investigator Protocol SMR/0211OBD-1003, A Multicenter,Randomized, Placebo-controlled, Double-blinded Study of theEfficacy and Safety of XXXX in Subjects with Opioid-inducedBowel Dysfuntion
Sub-Investigator Protocol RA0056, A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study with an Active Comparator to Evaluate the Efficacy and Safety of XXXX Administered Subcutaneously for 12 Weeks to Subjects with Active Rheumatoid Arthritis Having Previously Failed TNF-Blocker Therapy
Sub-Investigator Protocol RA0057, A Phase II Multi-Center, Open-Label, Follow-Up Study to Assess the Long-Term Safety and Efficacy of XXXX Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis who Completed Study RA0056
Sub-Investigator Protocol TGC-09201, A Phase II Study to Determine the Efficacy and Safety of XXXX Expressing XXXX in Patients with Grade 3 Chronic Degenerative Joint Disease of the Knee
Sub-Investigator Protocol CAIN457F2208, A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of XXXX in rheumatoid arthritis patients followed by an open label Extension
Principal Investigator Protocol D4300C00004, A Phase IIb, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of XXXX Compared with XXXX in Patients with Active Rheumatoid Arthritis
Principal Investigator Protocol D4300C00005, A Long-term Extension Study to Assess the Safety and Efficacy of XXXX in the Treatment of Rheumatoid Arthritis
Sub-Investigator CACZ885M2301: A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous XXXX in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP
Sub-Investigator MKC-TI-175, A phase III, Multicenter, Double-blind, Placebo-controlled, Randomized, Clinical Trial Evaluating the Efficacy and Safety of XXXX/ XXXX Insulin Inhalation Power Versus XXXX Inhalation Powder (Placebo) in Insulin Naive Subjects With Type 2 Diabetes Mellitus Poorly ;Controlled wit Oral Antidiabetic Agents Over a 24 Week Treatment Period
Principal Investigator IAP309: A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the XXXX PCA System/15mcg to Intravenous Patient-Controlled Analgesia with Morphine for the Treatment of Acute Post-Operative Pain
Sub-Investigator SAS115359: A Safety and Efficacy Study of Inhaled XXXX/XXXX versus Inhaled XXXX in the Treatment of Adolescent and Adult Subjects with Asthma
Sub-Investigator HZC113782: A Clinical Outcomes Study to compare the effect of XXXX/XXXX 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease
Principal Investigator AUX-CC-870: A Phase IIa, Open-Label, Dose-Ranging Study of the Safety and Effectiveness of XXXX for the treatment of Adhesive Capsulitis of the Shoulder
Sub-Investigator CC-10004-AS-001: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXXX in the Treatment of Active Ankyloosing Spondylitis
Sub-Investigator 27018966IBS3001: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy, Safety and Tolerability of XXXX in the Treatment of Patient With Diarrhea-Predominant Irritable Bowel Syndrome
Principal Investigator HYD3002: A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of XXXX Tablets 20 to 120 mg Once-daily in Subjects with Moderate to Severe Chronic Low Back Pain
Principal Investigator ONU3704: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of XXXX/XXXX Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to XXXX Controlled-release Tablets (OXY) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy
Principal Investigator X052160: A Phase II poof-of-concept study of XXXX in active inflammatory, erosive osteoarthritis of the hand
Sub-Investigator CC-10004-PSA-004: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study of Two Doses of XXXXXXXXXX (XX-XXXXX) in Subjects with Active Psoriatic Arthritis and a Qualifying Psoriasis Lesion
Sub-Investigator 5945-SOIC-12-05: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Long-term Safety and Tolerability of XX-XXXX for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain
Sub-Investigator GRT-MD-101: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Safety and Efficacy of XXXXXXX in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Sub-Investigator 27018966IBS3001: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of XXX-XXXXXXXX in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Sub-Investigator Protocol H9B-MC-BCDT: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous XXXXXXXXX in Patients with Systemic Lupus Erythematosus (SLE)
Sub-Investigator Protocol H9B-MC-BCDX: A Phase IIIb, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous XXXXXXXXX in Patients with Systemic Lupus Erythematosus (SLE) ( ILLUMINATE-X)
Principal Investigator I1Q-MC-JDDE: a Phase II randomized Study to Investigate the Efficacy and Safety of XXXXXXXXX Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty (eTHA)
Sub-Investigator Protocol 71040701: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of XXXXXXXXXX XXXXXX 1% Gel (Anchen Pharmaceuticals, Inc.) with Voltaren® Gel (diclofenac sodium topical gel) 1% (Novartis) in Patients with Osteoarthritis of the Knee
Sub-Investigator B0151006: A double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy and safety of XX-XXXXXXXX in subjects with systemic lupus erythematosus (SLE)
Sub-Investigator 35GA1203: A Multi‑center, Randomized, Double‑Blind, Saline‑Controlled Study of a Single Injection of Durolane® versus a Single Injection of Phosphate Buffered Saline (PBS) to Treat Pain Associated with Osteoarthritis of the Knee
Sub-Investigator BA058-05-003:A Randomized, Double-blind, Placebo-controlled, Comparative Phase III Multicenter Study to Evaluate the Safety and Efficacy of XXXXX for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women with Severe Osteoporosis and at Risk of Fracture
Sub-Investigator BC28027: A Phase IIIb Study To Evaluate the Potential of XXXXXXXXXXX to Reduce Cardiovascular Risk in Patients with Stable Cardiovascular Disease and Glucose Abnormalities
Sub-Investigator M5I02: Safety and Immunogenicity of XXXX-XXXXXX (XXXX and XXXX) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age
Principal Investigator X052161: An Open-label Safety Extension Study of XXXXXXXXXXX in Active Inflammatory, Erosive Osteoarthritis of the Hand (Extension of Study X052160)
Principal Investigator X052162: A Phase II Proof-of-concept Study of XXXXXXXXXXX in Subjects with Inflammatory Erosive Osteoarthritis of the Hand, X052162
Principal Investigator ZAL160-LSR-201: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXXX in Subjects with Neuropathic Pain from Lumbosacral Radiculopathy
Sub-Investigator Gel/1133: A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection of XXX-XXX® for the Treatment of Osteoarthritis of the Knee with Open-Label Safety Extension
Principal Investigator 6603/1131: A Multicenter, Randomized, Double-blind, Controlled, Comparative Study of XX-XXXX in Patients with Lumbar Disc Herniation (Phase III)
Sub-Investigator TGC-B106727: Long-Term Safety Follow-Up of Study Subjects Who Were Previously Enrolled in a XXXXXXXXXX Clinical Trial and Were Administered XXXXXXXXXX-X
Sub-Investigator 5945-SOIC-12-04 : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of XX-XXXX for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain
Principal Investigator FX006-2014-006: A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of XXXXX for the Treatment of Pain in Patients with Osteoarthritis of the Knee
Principal Investigator SKK-1132: A Multicenter, Open-label Study of XXX in Patients with Lumbar Disc Herniation (Phase III)
Principal Investigator AV01.2015-0863: A Double-Blind, Randomized, Study of the Effectiveness and Safety of XXX for the Treatment of Osteoarthritis of the Knee
Sub-Investigator M15-555: A Phase 3, Randomized, Double-Blind Study Comparing XXX Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX
Sub-Investigator M13-542: A Phase 3, Randomized, Double-Blind Study Comparing XXX to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Sub-Investigator ALX0061-C204: A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, dose-range Finding Study to Evaluate the Safety and Efficacy of XXX Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus
Principal Investigator 205180: A Phase IIa, Double-Blind, Mechanistic Study of XXX in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs
Principal Investigator 166770-005CL: A Randomized, Double Dummy, Parallel Arm, Placebo- And Active Controlled, Double-Blind, Study of the Safety and Efficacy of XXX as Monotherapy in Adults with Moderate-to-Severe Knee Pain Due to Osteoarthritis who are Inappropriate for Oral Non-Steroidal Anti-Inflammatory Therapy.
A Multicenter, Randomized, Double-blind, Controlled, Comparative Study of XXX in Patients with Lumbar Disc Herniation (Phase III)
A Multi-Center, Randomized, Double-Blind, Phosphate Buffered Saline-Controlled Study to Evaluate Effectiveness and Safety of a Single Intra-Articular Injection ofGel-One® for the Treatment of Osteoarthritis of the Knee With Open-Label Safety Extension - 2015
Seikagaku Corporation. A Multicenter, Open-label Study of XXX in Patients With Lumbar Disc Herniation (Phase III) – 2015
Actavis Inc. A Double-Blind, Randomized, Study of the Effectiveness and Safety of XXX for Treatment of Osteoarthritis of the Knee - 2015
A Randomized, Double-blind, Placebo-controlled, Event Driven Trial of Quarterly Subcutaneous XXX in the Prevention of Recurrent Cardiovascular Events Among Stable Post-Myocardial Infarction Patients With Elevated hsCRP – 2015
A Phase 3, Randomized, Double-Blind Study Comparing XXX to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) – 2016
