Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171691
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 Voltaren in the treatment of knee osteoarthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Diclofenac Topical Sodium Gel 1% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety of Diclofenac Sodium Gel in Knee Osteoarthritis |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence of treatment-emergent adverse events
- Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 450 |
| Study Start Date: | October 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT00171691
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171691
Locations
| United States, New Jersey | |
| Novartis Consumer Health Inc. | |
| Parsippany, New Jersey, United States | |
Sponsors and Collaborators
Novartis
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00171691 History of Changes |
| Other Study ID Numbers: | VOSG-PN-309 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal |
Antirheumatic Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015