Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Key facts

Study ID

NCT00722852

Run by

IDEA AG

People needed

555

Starts

2008-06-01

Expected to finish

2009-04-01

Last updated by the study team

2009-10-05

Who can join

Age: 46 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.