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Arthritis, Gout, Osteoporosis, and Pain Clinical Trials

 

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, 3-STAGE, EFFICACY AND SAFETY STUDY OF NI-071 AND US-LICENSED REMICADE® (INFLIXIMAB) FOR THE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS
(PRINCIPAL INVESTIGATOR, 2016)

AN OPEN LABEL PHASE II MULTIPLE DOSE SAFETY, PHARMACOKINETIC AND PHARMACODYNAMICS STUDY OF SEL-212 FOLLOWED BY OPEN LABEL ADMINISTRATION OF SEL-037 IN SUBJECTS WITH SYMPTOMATIC GOUT AND ELEVATED BLOOD URIC ACID.
(PRINCIPAL INVESTIGATOR, 2016)

A PHASE 3 DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF NKTR-181 IN OPIOID-NAÏVE SUBEJCTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN
(PRINCIPAL INVESTIGATOR, 2015)

A PHASE 3 MULTICENTER, OPEN-LABEL, 52-WEEK STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF NKTR-181 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN OR CHRONIC NONCANCER PAIN
(PRINCIPAL INVESTIGATOR, 2015)

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL, PHASE 3B STUDY TO EVALUATE THE CARDIOVASCULAR SAFETY AND EFFICACY OF FEBUXOSTAT AND ALLOPURINOL IN SUBJECTS WITH CARDIOVASCULAR COMORBIDITIES, HYPERURICEMIA, AND GOUT.
(PRINCIPAL INVESTIGATOR, 2015)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ARHALOFENATE FOR PREVENTING FLARES AND REDUCING SERUM URIC ACID IN GOUT PATIENTS
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 3 RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FEBUXOSTAT 40 MG XR, 80 MG XR, 40 MG IR, AND 80 MG IR IN SUBJECTS WITH GOUT
(PRINCIPAL INVESTIGATOR, 2014)

A PHASE 2, ENRICHED-ENROLLMENT, RANDOMIZED-WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, TOLERABILITY, AND SAFETY OF NKTR-181 IN OPIOID-NAIVE SUBJECTS WITH MODERATE TO SEVERE CHRONIC PAIN DUE TO OSTEOARTHRITIS OF THE KNEE  
(PRINCIPAL INVESTIGATOR, 2013)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LESINURAD MONOTHERAPY COMPARED TO PLACEBO IN SUBJECTS WITH GOUT AND AN INTOLERANCE OR CONTRAINDICATION TO XANTHINE OXIDASE INHIBITOR (LIGHT) 
(PRINCIPAL INVESTIGATOR, 2012)

LONG-TERM ALLOPURINOL SAFETY STUDY EVALUATING OUTCOMES IN GOUT PATIENTS (LASSO)  
(PRINCIPAL INVESTIGATOR, 2011)

A MULTICENTER, RANDOMIZED, ACTIVE-CONTROL, PHASE 3B STUDY TO EVALUATE THE CARDIOVASCULAR SAFETY OF FEBUXOSTAT AND ALLOPURINOL IN SUBJECTS WITH GOUT AND CARDIOVASCULAR COMORBIDITIES.  
(PRINCIPAL INVESTIGATOR, 2010)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF JNJ-42160443 AS ADJUNCTIVE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE KNEE OR HIP PAIN FROM OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3 RANDOMIZED, DOUBLE-BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
(PRINCIPAL INVESTIGATOR, 2010)

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECT OF A SINGLE INJECTION OF SAR164877 (REGN475) ON REDUCTION OF PAIN FROM VERTEBRAL FRACTURE ASSOCIATED WITH OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR, 2010)

A PHASE 3, 53 WEEKS STUDY ON ANALGESIC EFFICACY AND SAFETY OF NAPROXICINOD (HCT 3012): 26 WEEK, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO (13 WEEKS) AND NAPROXEN (26 WEEKS) CONTROLLED, MULTICENTER STUDY OF NAPROXICINOD (375 MG BID AND 750 MG BID) WITH A 26 WEEK NAPROXEN-CONTROLLED SAFETY FOLLOW-UP IN SUBJECTS WITH OSEOARTHRITIS OF THE KNEE AND A 1 WEEK POST TREATMENT SAFETY FOLLOW-UP.
(PRINCIPAL INVESTIGATOR, 2009)

A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL OF [S,S]-REBOXETINE IN PATIENTS WITH CHRONIC PAINFUL DIABETIC PERIPHERAL NEUROPATHY
(PRINCIPAL INVESTIGATOR, 2008)

A MULTI-CENTER, LONG-TERM, OPEN-LABEL EXTENSION STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIA
(PRINCIPAL INVESTIGATOR, 2008)

A 14-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY (QD) IN PATIENTS WITH FIBROMYALGIA
(PRINCIPAL INVESTIGATOR 2008)

A MULTICENTER, RANDOMIZED, CROSS-OVER, OPEN-LABEL STUDY TO EVALUATE THE ADHERENCE, PREFERENCE, AND SATISFACTION OF DENOSUMAB AND ALENDRONATE IN POSTMENOPAUSAL WOMEN WITH LOW BONE MINERAL DENSITY.
(PRINCIPAL INVESTIGATOR, 2007)

A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, RADIOGRAPHIC STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED SD-6010 IN SUBJECTS WITH SYMPTOMATIC OSTEOARTHRITIS OF THE KNEE
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF ODANACATIB (MK-0822) TO REDUCE THE RISK OF FRACTURE IN OSTEOPOROTIC POSTMENOPAUSAL WOMEN TREATED WITH VITAMIN D AND CALCIUM
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III, VARIABLE-DOSE TITRATION FOLLOWED BY A RANDOMIZED DOUBLE-BLIND STUDY OF CONTROLLED-RELEASE OROS HYDROMORPHONE HCL (NMED-1077) COMPARED TO PLACEBO IN PATIENTS WITH CHRONIC LOW BACK PAIN
(PRINCIPAL INVESTIGATOR, 2007)

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 CELECOXIB WITH NAPROXEN AND IBUPROFEN
(PRINCIPAL INVESTIGATOR, 2007)

A TWO WEEK,RANDOMIZED,DOUBLE BLIND,PLACEBO AND POSITIVE CONTROLLED,PARALLEL GROUP,MULTICENTRE STUDY TO ASSESS THE EFFICACY AND TOLERABILITY OF PF-00592379 IN PATIENTS WITH MODERATE TO SEVERE PAIN DUE TO OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ALLOPURINOL-CONTROLLED STUDY ASSESSING THE EFFICACY AND SAFETY OF ORAL FEBUXOSTAT IN SUBJECTS WITH GOUT
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE 3, 53 WEEKS STUDY ON ANALGESIC EFFICACY AND SAFETY OF NAPROXICINOD (HCT 3012): 26-WEEK, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO (13 WEEKS)- AND NAPROXEN (26 WEEKS)-CONTROLLED, MULTICENTER STUDY OF NAPROXICINOD (375MG BID AND 750MG BID) WITH A 26-WEEK NAPROXEN-CONTROLLED SAFETY FOLLOW-UP IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE, AND A 1-WEEK POST-TREATMENT SAFETY FOLLOW-UP
(PRINCIPAL INVESTIGATOR, 2007)

PRECISION: PROSPECTIVE, RANDOMIZED EVALUATION OF CELECOXIB INTEGRATED SAFETY VS IBUPROFEN OR NAPROXEN
(PRINCIPAL INVESTIGATOR, 2007)

A PHASE III, 12 WEEK, MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, PLACEBO- AND ACTIVE COMPARATOR-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GW406381, 5MG, 10MG, 25MG, AND 50MG ADMINISTERED ORALLY ONCE DAILY, IN ADULTS WITH RHEUMATOID ARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2006)

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND POSITIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF ORAL DOSES OF CJ-023,423 ADMINISTERED FOR 4 WEEKS TO SUBJECTS WITH OSTEOARTHRITIC PAIN OF THE KNEE.
(PRINCIPAL INVESTIGATOR, 2006)

A PHASE 3, RANDOMIZED, MULTICENTER, DOUBLE-BLIND STUDY COMPARING THE ANALGESIC EFFICACY OF EXTENDED RELEASE HYDROCODONE/ACETAMINOPHEN TABLETS (VICODIN CR) TO PLACEBO IN SUBJECTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR, 2006)

EFFECTS OF ARZOXIFENE ON VERTEBRAL FRACTURE INCIDENCE AND ON INVASIVE BREAST CANCER INCIDENCE IN POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS OR WITH LOW BONE DENSITY WITHOUT OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR, 2005)

A 4-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF L-000904218
IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
(PRINCIPAL INVESTIGATOR, 2005)

A 12-WEEK RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND STUDY TO ASSESS THE SAFETY AND EFFICACY OF ETORICOXIB 30MG VERSUS IBUPROFEN 2400MG IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2004)

A 26-WEEK, RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 2-PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF ETORICOXIB 30MG VERSUS CELECOXIB 200 MG IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 2004)

RANDOMIZED, DOUBLE-BLIND, MULITCENTER, ACTIVE COMPARATOR STUDY TO DETERMINE THE EFFICACY AND SAFETY OF BTDS 20 OR OXYIR VERSUS BTDS 5 IN SUBJECTS WITH MODERATE TO SEVERE OSTEOARTHRITIS (OA) PAIN
(PRINCIPAL INVESTIGATOR, 2004)

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ETORICOXIB 90 MG A DAY VERSUS DICLOFENAC SODIUM 50 MG TID IN PATIENTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR 2003)

A RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY OF ETORICOXIB IN PATIENTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS
(PRINCIPAL INVESTIGATOR 2003)

A PHASE II STUDY ON ANALGESIC EFFICACY, SAFETY, AND TOLERABILITY OF AR-P900758XX: A SIX-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING, MULTI-CENTRE STUDY COMPARING AR-P900758XX WITH VIOXX AND WITH NAPROXEN IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE
(PRINCIPAL INVESTIGATOR, 2002)

DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING TRIAL TO EVALUATE THE EFFICACY OF ATORVASTATIN ON BONE MINERAL DENSITY AND MARKERS FOR BONE TURNOVER IN POSTMENOPAUSAL WOMEN WITH DYSLIPIDEMIA AND AT RISK FOR OSTEOPOROSIS
(PRINCIPAL INVESTIGATOR 2001)

CERIVASTATIN FOR HYPERLIPIDEMIA AFTER REACHING MENOPAUSE (CHARM): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP, 6 -WEEK EVALUATION OF CERIVASTATIN 0.4 MG AND ATORVASTATIN 10 MG IN POST MENOPAUSAL WOMEN WITH HYPERLIPIDEMIA AND A 46 WEEK EVALUATION IN WHICH CERIVASTATIN 0.4 MG AND CERIVASTATIN 0.8 MG ARE COMPARED TO FENOFIBRATE 201 MG FOR LONG-TERM LIPID-LOWERING AND BONE MINERAL DENSITY EFFECTS.
(PRINCIPAL COINVESTIGATOR, 1999 - 2001)

AN 86-WEEK, DOUBLE-BLIND, ACTIVE COMPARATOR-CONTROLLED EXTENSION TO THE 1 - YEAR, RANDOMIZED, PLACEBO- AND ACTIVE COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, 2 PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0663 VERSUS IN PATIENTS WITH OSTEOARTHRITIS
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN TREATED HYPERTENSIVE PATIENTS WITH OSTEOARTHRITIS (SUCCESS VII)
(PRINCIPAL INVESTIGATOR, 2000 - 2001)

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, ACTIVE- AND PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY CONDUCTED UNDER IN-HOUSE BLINDING CONDITIONS TO DETERMINE THE INCIDENCE OF GASTRODUODENAL ULCERS IN PATIENTS WITH RHEUMATOID ARTHRITIS AFTER 12 WEEKS OF TREATMENT WITH MK-0663, NAPROXEN, OR PLACBO
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN HYPERTENSIVE PATIENTS WITH PERIPHERAL OSTEOARTHRITIS TAKING ANTIHYPERTENSIVE MEDICATIONS (SUCCESS-VI)
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

A 1-YEAR, RANDOMIZED, PLACEBO- AND ACTIVE-COMPARATOR-CONTROLLED, PARALLEL-GROUP, DOUBLE-BLIND, TWO PART STUDY TO ASSESS THE SAFETY AND EFFICACY OF MK-0663 VERSUS NAPROXEN IN PATIENTS WITH OSTEOARTHRITIS.
(PRINCIPAL INVESTIGATOR, 1999 - 2000)

ASSESSMENT OF DIFFERENCES BETWEEN VIOXX AND NAPROXEN TO ASCERTAIN GASTROINTESTINAL TOLERABILITY AND EFFECTIVENESS (ADVANTAGE) - A RANDOMIZED, DOUBLE BLIND, MULTICENTER STUDY TO EVALUATE THE TOLERABILITY AND EFFECTIVENESS OF ROFECOXIB (MK-0966) 25 MG QD VS NAPROXEN 500 MG BID IN PATIENTS WITH OSTEOARTHRITIS.
(SUBINVESTIGATOR, 1999 - 2000)

DEVELOPMENT AND VALIDATION OF A PREDICTIVE MODEL FOR FACILITATION OF DIAGNOSIS OF LOW BONE MASS IN PERIMENOPAUSAL AND POSTMENOPAUSAL WOMEN
(PRINCIPAL INVESTIGATOR 1994-1995)

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