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Sponsored by: |
IDEA AG |
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Information provided by: | IDEA AG |
ClinicalTrials.gov Identifier: | NCT00716547 |
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis of the Knee |
Drug: ketoprofen in Diractin® Drug: Placebo Drug: celecoxib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee |
Estimated Enrollment: | 1320 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ketoprofen in Diractin®
50 mg (b.i.d.)
|
2: Experimental |
Drug: ketoprofen in Diractin®
100 mg (b.i.d.)
|
3: Active Comparator |
Drug: celecoxib
100 mg (b.i.d.)
|
4: Placebo Comparator |
Drug: Placebo
b.i.d.
|
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
Ages Eligible for Study: | 46 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
IDEA Investigational Site | Recruiting |
Prague 2, Czech Republic, 128 50 | |
Contact: Karel Pavelka, Prof. M.D. +49-89-324633-0 idea@idea-ag.de | |
Principal Investigator: Karel Pavelka, Prof. M.D. | |
Germany | |
Klaus-Miehlke-Klinik | Recruiting |
Wiesbaden, Germany, 65191 | |
Contact: Wolfgang Bolten, M.D. +49-89-324633-0 idea@idea-ag.de | |
Principal Investigator: Wolfgang Bolten, M.D. | |
Poland | |
NZOZ Nasz Lekarz | Recruiting |
Torun, Poland, 87-100 | |
Contact: Slawomir Jeka, M.D. +49-89-324633-0 idea@idea-ag.de | |
Principal Investigator: Slawomir Jeka, M.D. | |
United Kingdom | |
Chapel Allerton Hospital | Recruiting |
Leeds, United Kingdom, LS7 4SA | |
Contact: Philip Conaghan, MB BS PhD FRACP FRCP +49-89-324633-0 idea@idea-ag.de | |
Principal Investigator: Philip Conaghan, MB BS PhD FRACP FRCP |
Study Director: | IDEA AG Clinical Trial | IDEA AG |
Responsible Party: | IDEA AG ( Dr. Claudia Himly / Director of Clinical Operations ) |
Study ID Numbers: | CL-033-III-03 |
Study First Received: | July 14, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00716547 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Ketoprofen Osteoarthritis, Knee Celecoxib Musculoskeletal Diseases |
Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |