Back to resultsSafety of Diclofenac Sodium Gel in Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Topical Sodium Gel 1%
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Eligibility 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
Sites / Locations
- Novartis Consumer Health Inc.
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171691
Brief Title
Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official Title
Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diclofenac Topical Sodium Gel 1%
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Title
Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
Secondary Outcome Measure Information:
Title
Incidence of serious treatment-emergent adverse events
Title
Number of patients who discontinued study medication due to a treatment-emergent adverse event
Title
WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novartis Consumer Health Inc.
City
Parsippany
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22030938
Citation
Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918.
Results Reference
derived
Learn more about this trial
Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
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