Back to resultsEfficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Primary Purpose
Osteearthritis
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 Osteearthritis focused on measuring Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Eligibility Criteria
Key Inclusion criteria OA 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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171678
Brief Title
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official Title
Efficacy and 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
August 2005 (Actual)
Study Completion Date
August 2005 (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 diclofenac sodium gel 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
Osteearthritis
Keywords
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Diclofenac Topical Sodium Gel 1%
Primary Outcome Measure Information:
Title
WOMAC pain score in target knee at Week 12
Title
WOMAC physical function score in target knee at Week 12
Title
Global rating of disease activity by patient at Week 12
Secondary Outcome Measure Information:
Title
WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
Title
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
Title
Pain on movement in target knee and use of rescue medication recorded in diary
Title
Global evaluation of treatment at final visit
Title
Treatment responder rate according to OARSI criteria
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion criteria
OA 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
21174485
Citation
Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
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