Research Experience

  • Efficacy in controlling glycaemia with XXX as add-on to metformin vs YYY as add-on to metformin after 104 weeks of treatment in subjects with T2DM inadequately controlled with metformin monotherapy and treated in a primary care setting. Phase 4. (2016-Present). Principal Investigator: Daniel Pomposini, MD

  • A Randomized, open label, parallel group real world pragmatic trial to assess the clinical and health outcomes of XXX compared to commercially available basal insulins for initiation of therapy in insulin naïve patients with uncontrolled T2DM. Phase 4. (2015-Present). Principal Investigator: Daniel Pomposini, MD

  • Glycemic Control and Treatment Satisfaction Using XXX vs YYY for initiating bolus insulin dosing in T2DM patients not achieving glycemic targets on basal insulin with/without antihyperglycemic agents. (2015-ongoing). Device Study. Principal Investigator: Daniel Pomposini, MD

  • A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with XXX in Patients Treated with SOC for T2DM. Device Study (2015). Principal Investigator: Daniel Pomposini, MD
     
  • A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Long Term Treatment with XXX on the incidence of Major Adverse CV events and conversion to T2DM in obsess and overweight subjects with CV disease or multiple risk factors. (April 2014-Present). Principal Investigator: Daniel Pomposini, MD

  • A Multicenter, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Effect of XXX on the Incidence of CV death, MI, or Ischemic Stroke with Type 2 Diabetes. Phase 3B. (2013-Present). Principal Investigator: Daniel Pomposini, MD

  • A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of XXX in addition to Standard of Care in Subjects with Type 2 Diabetes and with CV Disease or Multiple Risk factors for CV Disease. (2013-2014). Principal Investigator: Daniel Pomposini, MD

  • A Phase 3, Randomized, Double blind, Placebo controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Patients with type 2 Diabetes. (April 2013-2015). Principal Investigator: Daniel Pomposini, MD

  • A Randomized, Multicenter Study to Evaluate Cardiovascular Outcomes with XXX in Patients Treated with Standard of Care for Type 2 Diabetes. (June 2013-2016). Principal Investigator: Daniel Pomposini, MD

  • Multicenter, Randomized, Double Blind, Placebo Controlled, 8 week study to evaluate the efficacy and safety of XXX and YYY given as a fixed-Dose Combination in Patients with Stage 1 or 2 Essential Hypertension. (June 2012-2013). Principal Investigator: Daniel Pomposini, MD

  • Multicenter, Double Blind, Crossover Design Study to Evaluate Lipid-Altering Efficacy and Safety of XXX in Patients with Primary Hypercholesterlemia or Mixed Dyslipidemia (May 2011-April 2012), Phase 3. Principal Investigator: Daniel Pomposini, MD

  • A Randomized, Double Blind, Placebo Controlled, Event driven trials of quarterly subcutaneous XXX in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. (May 2011-Present). Phase 3. Principal Investigator: Daniel Pomposini, MD

  • A Randomized, Double Blind, Placebo Controlled, Parallel Group Study on the Efficacy and Safety of XX as Add on to YYY Therapy for Type 2 Diabetes Mellitus. (February 2011-March 2012). Phase 3b/4. Principal Investigator: Daniel Pomposini, MD

  • A Randomized Double Blind, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of XXX Versus YYY in the Treatment of Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic control on Metformin and Sulfonylurea. (June 2010-May 2012) Phase 3. Principal Investigator: Daniel Pomposini, MD

  • A 24 week, multicenter, randomized, double blind, age stratified, placebo controlled phase III study with a 28 week extension period to evaluate the efficacy and safety of XXX in patients with type 2 diabetes, cardiovascular disease and hypertensions, who exhibit inadequate glycemic control on usual care. (February 2010-2012). Phase 3. Principal Investigator: Daniel Pomposini, MD

  • A 26-week randomized, confirmatory, controlled, open label, multicenter, multinational treat-to-target trial comparing the efficacy and safety of xxx and yyy, both injected once daily in combination with oral anti-diabetic drugs (OADs), in insulin naïve subjects with type 2 diabetes mellitus currently treated with OADs qualifying for intensified treated. Phase 3a. Principal Investigator: Daniel Pomposini, MD/Back-up site

  • A Randomized, Multicenter, Double Blind, Parallel, Placebo Controlled study of the effects of XXX on cardiovascular outcomes in Adult subjects with type 2 Diabetes Mellitus. (2009-Present). Phase 3. Principal Investigator: Daniel Pomposini, MD

  • A Randomized, Double Blind, Parallel-group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease. Phase 4. Comparing XXX with YYY and ZZZ. (2009-2016). Principal Investigator: Daniel Pomposini, MD

  • Observational study of men and women with osteoarthritis who have been prescribed XXX. (2004-2010). Principal Investigator: Daniel Pomposini, MD

  • An Observational, Multicenter study of Hypertension Management, Persistence, Compliance, and Blood Pressure Control. (2006-2008). Principal Investigator: Daniel Pomposini, MD

  • Efficacy and Safety of a Standard Titration Algorithm Coupled with a Conventional Dietary Intervention or Intensive Dietary Intervention VS. a Standard Titration Algorithm, Alone, in Patients with Type 2 Diabetes Initiating XXX Therapy. (2004-2006). Principal Investigator: Daniel Pomposini, MD

  • Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein: A Multicenter, Randomized, Open Label, 2 Arm Parallel Group Study to Evaluate the Efficacy of Moderate vs. Aggressive Antihypertensive Therapy with XXX and YYY to Reduce Blood Pressure and Plasma hsCRP levels in Patients with Stage 2 Hypertension. (2004-2005). Principal Investigator: Daniel Pomposini, MD

  • A multicenter case control clinical study to identify genotypic factors in symptomatic patients with develop de novo deep vein thrombosis. (January 2004-May 2004). Principal Investigator: Daniel Pomposini, MD

  • Phase 3, Randomized Withdrawal Double Blind Study of XXXX Monotherapy Compared to XXXX Monotherapy for Maintenance of Remission in Subjects with Rheumatoid Arthritis. (2015-Present). Principal Investigator: Sharukh D. Shroff, MD

  • A Phase 3, Multicenter, Double Blind, Randomized, Controlled Study of XXXX and XXXX in Combination or as Monotherapy in Subjects with Psoriatic Arthritis. (2015-Present). Principal Investigator: Sharukh D. Shroff, MD

  • A Phase 3B, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of XXXX SC in Combination with XXXX Compared to XXX Monotherapy in Achieving Clinical Remissison in Adults with Early Rheumatoid Arthritis who are XXXX Naïve. (2015-Present). Principal Investigator: Sharukh D. Shroff, MD

  • Efficacy, Safety, and immunogenicity of XXX vs YYY in patients with active rheumatoid arthritis: a randomized double blind, parallel arm, multiple dose, active comparator trial. (2015-Present). Ongoing Ext Study.). Phase 3. Principal Investigator: Sharukh D. Shroff, MD

  • A Randomized, Double Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Effect on Radiographic Progression of XXX in Subjects with Psoriatic Arthritis. (February 2014-2015). Principal Investigator: Sharukh D. Shroff, MD

  • A Phase IIb, Multicenter, Randomized, Double Blind, Placebo Controlled, Multidose, 24 Week Study to Evaluate the Efficacy and Safety of XXX in Subjects with Systemic Lupus Erythmatosus (SLE). Phase 2b. Principal Investigator: Sharukh D. Shroff, MD

  • Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter, Worldwide, Proof of Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX in subjects with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Anti-TNF Therapy. (May 2013-October 2013). Principal Investigator: Sharukh D. Shroff, MD

  • A 5 Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated with or without XXX (2013-Present). Principal Investigator: Sharukh D. Shroff, MD

  • A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of XXX in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors. Phase 3b. (2012-2013). Principal Investigator: Sharukh D. Shroff, MD

  • A Phase 3B, Multicenter, Open Label Study to evaluate the Long Term Safety and Efficacy of Subcutaneous XXX in Patients with Systemic Lupus Erythematosus (SLE) Phase 3B. (April 2012-2015). Principal Investigator: Sharuhk D. Shroff, MD

  • A Multicenter Randomized, Double Blind, Placebo Controlled Study to evaluate the Efficacy and Safety of Subcutaneous XXX in Patients with Systemic Lupus Erythematosus (SLE) Phase 3. (March 2011-2015). Principal Investigator: Sharukh D. Shroff, MD.

  • A Phase 3, Randomized, Double Blind, Placebo Controlled, Multicenter Study of the analgesic efficacy and safety of a does titration regiment for the subcutaneous administration of XXX in subjects with osteoarthritis of the hip or knee. (2016-Present). Principal Investigator: Mark Hermann, MD

  • A Phase 3, Randomized, Double Blind, Placebo Controlled, Multicenter Study of the analgesic efficacy and safety of a does titration regiment for the subcutaneous administration of XXX in subjects with osteoarthritis of the hip or knee. (2016-Present). Principal Investigator: Mark Hermann, MD

  • A Phase 2A, Randomized, Double Blind, Placebo Controlled crossover study of the Safety and Efficacy of XXX in subjects with Osteoarthritis of the knee. (2016-Present). Principal Investigator: Mark Hermann, MD

  • Prospective, Multicenter, Single Arm Pilot Clinical Investigation Evaluating the use of a Surface Bleeding Severity Scale and the Safety and Efficacy of a new hemostatic device in abdominal and orthopedic lower extremity surgeries. (2015-2016). Device Study. Principal Investigator: Mark Hermann, MD

  • Prospective, Multicenter, Randomized, Three-Arm, Parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular does of 2ml of Investigational Product as compared to Placebo and XXXX injected into the target knee for the treatment of pain in subjects with Osteoarthritis. (2015). Device Study. Principal Investigator: John Mahoney, MD 

  • Double Blind, Placebo Controlled, Randomized, Parallel-group Study to Determine the Safety and Efficacy of a Topical Patch (XXXX) Following Daily Administration for 2 Weeks in Patients with Chronic Low Back Pain. Phase 2. (2015-2015). Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, Sham-Controlled Pilot Study of XXXX Therapy in the Treatment of Persistent Post-Operative Pain following a Total Knee Arthropasty (Device Study). (2015-2016). Principal Investigator: John Mahoney, MD

  • A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of XXX, XXX, XXX, XXX in Subjects with Gout. (2014-2016). Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of a single intra-articular injection of XXX in adults with pain due to osteoarthritis of the knee. (January 2014-October 2014). Phase 3. Principal Investigator: Mark Hermann, MD

  • A Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of XXX for the Treatment of Adhesive Capsulitis of the Shoulder. Phase 2b. (December 2013-November 2014). Principal Investigator: Mark Hermann, MD

  • A Double Blind, Randomized, Parallel Group, Dose-Ranging Study to Assess the Safety and Efficacy of XXXX for the Treatment of Pain in Patients with Osteoarthritis of the Knee. (2014-2015). Principal Investigator: John Mahoney, MD

  • A Multicenter, Randomized, Double Blind, Parallel, Active Controlled Non-Inferiority Clinical Trial Comparing Three Weekly Intra-Articular Injections of XXXX Versus Three Weekly Intra-Articular Injections of XXX for the Treatment of Osteoarthritis Pain of the Knee. (2014-2015). Principal Investigator: Mark Hermann, MD. (Device Study)

  • Placebo Controlled, Double Blind Evaluation of the Efficacy and Safety of XXX for the treatment of Ankle Sprain. (November 2013-2015). Phase 3. Principal Investigator: Jonathan Krome, MD

  • A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Two Doses of intra-articular injections of XXX in adults with pain due to osteoarthritis of the knee (April 2013-August 2013). Phase 2. Principal Investigator: Mark Hermann, MD

  • A Randomized, Double Blind, Double Dummy, Placebo Controlled, Active Controlled, Parallel Group, Multicenter Trial of XXX to Assess the Analgesic Efficacy and the Management of Opioid Induced Constipation in Subjects with Moderate to Severe Chronic Low Back Pain and a history of OIC. (November 2012-2015). Phase 3. Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, Placebo Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of intra-articular injection of XXX in adults with pain due to osteoarthritis of the knee. (April 2013-August 2013). Phase 2. Principal Investigator: Mark Hermann, MD

  • A Randomized, Double-Blind, Double Dummy, Placebo Controlled, Active Controlled, Parallel Group, Multicenter Trial of XXX to Assess the Analgesic Efficacy and the Management of Opioid Induced Constipation in Subjects with Moderate to Severe Chronic Low Back Pain and a history of OIC. (November 2012-2015). Phase 3. Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, Double-Blind, Multicenter, Placebo Controlled, Combination Study to Evaluate the Efficacy and Safety of XXX and YYY compared to YYY Alone in Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout. (March 2012-2015) Phase 3. Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, Double-Blind, Multicenter, Placebo Controlled, Combination Study to Evaluate the Efficacy and Safety of XXX and YYY compared to YYY Alone in Subjects with Gout who had an inadequate hypouricemic response to Standard of Care YYY. (March 2012-2015). Phase 3. Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, double-blind, active controlled study of xxx or yyy vs. zzz for treating acute gouty arthritis flares in frequently flaring patients. Phase III. (2011-2014). Sponsor: Novartis. Principal Investigator: Joseph Campbell, Jr., MD

  • A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of XXX in patients with Systemic Lupus Erythematosus (SLE). (2011-present)Sponsor: Eli Lilly. Principal Investigator: Sharukh Shroff, MD

  • Multinational, prospective, Observational Study to characterize and assess the burden of refractory gouty arthritis on patients over one year. (2010-2011)Sponsor: Novartis: Principal Investigator: Joseph Campbell, MD

  • A Randomized, Multicenter, Double-Blind Factorial Comparator and Placebo Controlled Phase III Trial to Evaluate the Efficacy, Tolerability, and Safety of XXX in the treatment of ankle sprains. (2010-2011)
    Sponsor: IL Pharma. Principal Investigator: Mark Hermann, MD

  • A Randomized, Multicenter, Double-Blind Factorial Comparator and Placebo Controlled Phase III Trial to Evaluate the Efficacy, Tolerability, and Safety of XXX in the treatment of Tendonitis and Bursitis of the Shoulder (2010-2011) Sponsor: IL Pharma.. Principal Investigator: Mark Hermann, MD

  • Phase III, Randomized, controlled study of XXX on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDS and/or colchicine are contraindicated, not tolerated or ineffective. (2010-2011) Sponsor: Novartis. Principal Investigator: Joseph Campbell, Jr., MD

  • A Randomized, double blind, placebo controlled study to determine the efficacy of XXX in the treatment of pain caused by osteoarthritis of the knee. Phase III. Sponsor: Strategic Science & Technologies.
  • Principal Investigator: Mark Hermann, MD

  • A Randomized, Multicenter, Double-Blind, Placebo controlled study to evaluate the Efficacy and Safety of XXX in the treatment of pain associated with mild to moderate ankle sprain. Phase III. Sponsor: Hisamitsu.(2009-2010). Principal Investigator: Mark Hermann, MD

  • Observational Registry of Patients Using Prescription Medications Containing XXX for the treatment of pain. Phase IV. (2010).Sponsor: Ortho McNeil Janssen. Principal-Investigator: Joseph Campbell, Jr., MD

  • Phase III, Open Label, Randomized, Referred Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of XXX on Vitamin D Adequacy in the Treatment of Osteoporosis in Postmenopausal Women. (2008-2010). Sponsor: Merck. Principal Investigator: Stuart Kramer, M.D.

  • Study for the validation of XXX for Assessing Opioid-Induced Constipation/ Device Study (2008-2009) Sponsor: Johnson & Johnson. Principal Investigator: Joseph Campbell, Jr., M.D.

  • A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial of three injections of XXX For the treatment of Chronic Shoulder Pain Associated with Glenohumeral Osteoarthritis. (2008-2010). Sponsor: Smith & Nephew. Principal Investigator: Stuart Kramer, M.D.

  • A Phase III, Flexible-Dose Titration Followed by a Randomized Double Blind Study of Controlled Release XXX Compared to Placebo in Patients with Osteoarthritis Pain (2008). Opioid Study. Sponsor: Neuromed.Principal Investigator: Joseph Campbell, Jr., M.D.

  • A Randomized, Open Label, Blinded-Endpoint, Parallel Group Trial of GI Safety of XXX compared with NSAIDS in Osteoarthritis Patients . (2007-2010). Sponsor: Pfizer. Principal Investigators: Mark Hermann, M.D.; Stuart Kramer, M.D.; Joseph Campbell, Jr., M.D.; and Jonathan Krome, M.D.

  • Open Label Extension, Single Arm, Flexible Dosing, Phase III Trial with XXX in Subjects with Moderate to Severe Chronic Pain. (2008-2009). Opioid Study. Sponsor: Johnson & Johnson. Principal Investigator: Joseph Campbell, Jr., M.D.

  • Community Experience of Subjects with Osteoporosis Using the XXX (Device) to Self Administer Once Daily XXX Therapy.(2008). Sponsor: Eli Lilly. Principal Investigator: Stuart Kramer, M.D.

  • A Randomized, Double-Blind, Active- And Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of XXX In Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease. (2007). Opioid Study. Sponsor: Johnson & Johnson. Principal Investigator: Joseph Campbell, Jr., M.D.

  • A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety in Osteoarthritis or Rheumatoid Arthritis Patients with or at High Risk for Cardiovascular Disease Comparing XXX with YYY and ZZZ.(2006-present). Sponsor: Pfizer. Principal Investigator: Mark Hermann, M.D.

  • A Six week Double-blind, Randomized, Multi-center comparison Study of the analgesic effectiveness of XXX compared to YYY In Subjects with Chronic Low Back Pain. (2006) Sponsor: Pfizer. Principal Investigator: Mark Hermann, M.D.

  • Observational study of men and women with osteoporosis who have been prescribed XXX. (2004 2010). Sponsor: Eli Lilly. Principal Investigator: Stuart Kramer, M.D.

  • Multinational, Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel group study assessing the efficacy of intravenous XXX in preventing subsequent osteoporotic fractures after a hip fracture. Sponsor: Novartis. (2002-2007). Principal Investigator: Mark Hermann, M.D.

  • Multi-center, Double-Blind, Placebo Controlled, Randomized, Parallel Group study to compare the efficacy and tolerability of XXX vs. YYY in treatment of acute ankle sprains. (2002-2003). Principal Investigator: Mark C. Herman, M.D.

  • A Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group study to evaluate the safety of XXX in patients with Osteoarthritis Or Rheumatoid Arthritis. (2002-2006). Sponsor: Merck. Principal Investigator: Stuart Kramer, M.D.

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