Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Osteearthritis Clinical Trial

Official title:

Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171678
• Other study ID #: VOSG-PN-310
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 20, 2012
• Start date: October 2004
• Est. completion date: August 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteearthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac Topical Sodium Gel 1%

Locations

Country	Name	City	State
United States	Novartis Consumer Health Inc.	Parsippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC pain score in target knee at Week 12
Primary	WOMAC physical function score in target knee at Week 12
Primary	Global rating of disease activity by patient at Week 12
Secondary	WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
Secondary	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
Secondary	Pain on movement in target knee and use of rescue medication recorded in diary
Secondary	Global evaluation of treatment at final visit
Secondary	Treatment responder rate according to OARSI criteria

External Links

•   Novartis Clinical Trial Results Database