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Sponsored by: |
Pharmos |
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Information provided by: | Pharmos |
ClinicalTrials.gov Identifier: | NCT00484120 |
This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis of the Knee |
Drug: 3%-Diclofenac-Nano-Emulsion Cream |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Proof-of Concept Study to Evaluate the Safety and Analgesic Efficacy of Topical 3%-Diclofenac-Nano-Emulsion Cream Versus Placebo for Knee Osteoarthritis |
This will be a multi-center, double-blind, placebo-controlled, multiple-dose, parallel treatment study. A total of 126 subjects will be randomized to receive either 3%-Diclofenac-NE cream or a placebo cream respectively. Following screening and a washout period from previous treatments subjects will be enrolled and will self-apply the study medication. During the study, subjects will apply 3%-Diclofenac-NE or placebo cream three times daily for 28 days and complete a home-diary. Subjects will visit the clinic at mid-treatment for a follow up examination and again for a final examination at the end of treatment.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Rambam Medical Center | |
Haifa, Israel, 9602 | |
Sourasky Medical Center | |
Tel Aviv, Israel, 64239 | |
Assaf Harofeh Medical Center | |
Zerifin, Israel, 70300 |
Principal Investigator: | Eisenberg Elon, MD | Rambam Health Care Campus |
Study ID Numbers: | PH-2007-2 |
Study First Received: | June 7, 2007 |
Last Updated: | June 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00484120 |
Health Authority: | Israel: Ministry of Health |
Osteoarthritis Diclofenac Nano-emulsion |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Diclofenac Pain 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 |