Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
NCT ID: NCT00722852
Last Updated: 2009-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2008-06-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
ketoprofen in Diractin®
100 mg (b.i.d.)
2
Placebo
100 mg (b.i.d.)
Interventions
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ketoprofen in Diractin®
100 mg (b.i.d.)
Placebo
100 mg (b.i.d.)
Eligibility Criteria
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Inclusion Criteria
* Age \> 45 years
* Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Exclusion Criteria
* Directly or indirectly involved in the conduct and administration of this study
* Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
* Pregnancy or lactation
* Residents of psychiatric wards, prisons or other state institutions
* Malignancy within the past 2 years
* Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
* Epilepsy
* Schizophrenia
* Neuropathic pain and any other pain condition requiring chronic use of pain medication
* Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
* Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
* Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
46 Years
ALL
No
Sponsors
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IDEA AG
INDUSTRY
Responsible Party
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IDEA AG
Principal Investigators
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IDEA AG
Role: STUDY_DIRECTOR
IDEA AG
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Premiere Pharmaceutical Research
Tempe, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Family Practice Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Orange County Clinical Trails, Inc.
Anaheim, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Tampa Bay Medical Research Inc.
Clearwater, Florida, United States
University Clinical Research DeLand, LCC
DeLand, Florida, United States
Eastern Research
Hialeah, Florida, United States
DSI
Jupiter, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Suncoast Clinical Research Family Practice
New Port Richey, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Non-Surgical Orthopaedic & Spine Center, P.C.
Marietta, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Advance Clinical Research Insititute
Boise, Idaho, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Integrated Clinical Trail Services, Inc.
West Des Moines, Iowa, United States
Lousianna Research Associates Inc. (LRC, Inc)
New Orleans, Louisiana, United States
Future Care Studies
Springfield, Massachusetts, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States
Omaha Research, P.C.
Omaha, Nebraska, United States
Rochester Clinical Research
Rochester, New York, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
The Center of Clinical Research LLC
Winston-Salem, North Carolina, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Pharcotherapy Research Associate, Inc.
Zanesville, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Founders Research Group Research
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Goose Creek, South Carolina, United States
Sarah Cannon Research Institute
Jackson, Tennessee, United States
Quality Research Inc.
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Countries
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References
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Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
Other Identifiers
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CL-033-III-06
Identifier Type: -
Identifier Source: org_study_id
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