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: NCT00171691 |
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 : | 450 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

- Incidence of treatment-emergent adverse events
- Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
- Incidence of serious treatment-emergent adverse events
- Number of patients who discontinued study medication due to a treatment-emergent adverse event
- WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

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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): NCT00171691
United States, New Jersey | |
Novartis Consumer Health Inc. | |
Parsippany, New Jersey, United States |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171691 |
Other Study ID Numbers: |
VOSG-PN-309 |
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 |