Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Drug: Placebo
- Registration Number
- NCT00722852
- Lead Sponsor
- IDEA AG
- Brief Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.
- Detailed Description
The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 555
- Informed consent signed and dated
- 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
- Skin lesions or dermatological diseases in the treatment area
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ketoprofen in Diractin® - 2 Placebo -
- Primary Outcome Measures
Name Time Method pain subscale of the WOMAC week 12
- Secondary Outcome Measures
Name Time Method Patient global assessment of response to therapy week 12 function subscale of the WOMAC week 12
Trial Locations
- Locations (37)
Family Practice Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Premiere Pharmaceutical Research
🇺🇸Tempe, Arizona, United States
Pharcotherapy Research Associate, Inc.
🇺🇸Zanesville, Ohio, United States
Tampa Bay Medical Research Inc.
🇺🇸Clearwater, Florida, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
FPA Clinical Research
🇺🇸Kissimmee, Florida, United States
Orange County Clinical Trails, Inc.
🇺🇸Anaheim, California, United States
Encompass Clinical Research
🇺🇸Spring Valley,, California, United States
DSI
🇺🇸Jupiter, Florida, United States
University Clinical Research DeLand, LCC
🇺🇸Deland, Florida, United States
Eastern Research
🇺🇸Hialeah, 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
Clinical Research Atlanta
🇺🇸Stockbridge,, Georgia, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Non-Surgical Orthopaedic & Spine Center, P.C.
🇺🇸Marietta,, Georgia, United States
Advance Clinical Research Insititute
🇺🇸Boise, Idaho, United States
Westside Family Medical Center, P.C.
🇺🇸Kalamazoo, Michigan, United States
Lousianna Research Associates Inc. (LRC, Inc)
🇺🇸New Orleans,, Louisiana, 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
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Founders Research Group Research
🇺🇸Philadelphia, Pennsylvania, United States
Rapid Medical Research, Inc.
🇺🇸Cleveland, Ohio, United States
Coastal Carolina Research Center
🇺🇸Goose Creek,, South Carolina, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Sarah Cannon Research Institute
🇺🇸Jackson, Tennessee, United States
The Center of Clinical Research LLC
🇺🇸Winston-Salem, North Carolina, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Integrated Clinical Trail Services, Inc.
🇺🇸West Des Moines, Iowa, United States