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Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171626
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
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Purpose
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis | Drug: Diclofenac Topical Sodium Gel 1% | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 480 |
| Study Start Date: | August 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 35 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171626
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171626
Locations
| United States, New Jersey | |
| Novartis Consumer Health Inc | |
| Parsippany, New Jersey, United States | |
Sponsors and Collaborators
Novartis
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00171626 History of Changes |
| Other Study ID Numbers: |
VOSG-PN-304 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 20, 2012 |
Keywords provided by Novartis:
|
Knee osteoarthritis, Topical NSAID, Diclofenac sodium |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on August 18, 2017