Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00171626 |
Recruitment Status :
Completed
First Posted : September 15, 2005
Last Update Posted : April 23, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: Diclofenac Topical Sodium Gel 1% | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
Study Start Date : | August 2004 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | June 2005 |

- WOMAC pain score in target knee at Week 12
- WOMAC physical function score in target knee at Week 12
- Global rating of disease activity by patient at Week 12
- WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
- WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
- Pain on movement in target knee and use of rescue medication recorded in diary
- Global evaluation of treatment at final visit
- Treatment responder rate according to OARSI criteria

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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion criteria
- Osteoarthritis of the knee Key Exclusion criteria
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171626
United States, New Jersey | |
Novartis Consumer Health Inc | |
Parsippany, New Jersey, United States |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171626 |
Other Study ID Numbers: |
VOSG-PN-304 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | April 23, 2012 |
Last Verified: | April 2012 |
Knee osteoarthritis, Topical NSAID, Diclofenac sodium |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |