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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00426621 |
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
Condition | Intervention | Phase |
Osteoarthritis of the Knee |
Drug: Diclofenac Sodium Gel Drug: Placebo |
Phase III |
MedlinePlus related topics: | Osteoarthritis |
ChemIDplus related topics: | Diclofenac Diclofenac potassium Diclofenac sodium |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee. |
Enrollment: | 420 |
Study Start Date: | November 2006 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
1: Experimental |
Drug: Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
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2: Placebo Comparator |
Drug: Placebo
4 grams per knee, 4 times per day, for 12 weeks
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Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Show 65 Study Locations |
Novartis |
Principal Investigator: | Roy Altman, MD | University of California, in Los Angeles, Division of Rheumatology, 310 206 7866 |
Responsible Party: | University of California, in Los Angeles, Division of Rheumatology, ( Roy Altman ) |
Study ID Numbers: | VOSG-PN-316 |
First Received: | January 24, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00426621 |
Health Authority: | United States: Food and Drug Administration |
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