Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Diclofenac Sodium Gel; Drug: Placebo

• Registration Number: NCT00426621
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-25
• Study Completion: 2007-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-13
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Osteoarthritis of the knee

Exclusion Criteria

• Other rheumatic disease, such as rheumatoid arthritis
• Active gastrointestinal ulcer during the last year
• Known allergy to analgesic drugs
• Other protocol defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Diclofenac Sodium Gel	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary Outcome Measures

Name	Time	Method
Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Low pain intensity in either knee; and
Low functional impairment in either knee.
Safety of Diclofenac Sodium Gel 1% assessed by:
monitoring adverse events; and
laboratory evaluations.

Trial Locations

Locations (61)

Coastal Clinical Research Inc; 🇺🇸 Mobile, Alabama, United States

River Region Research, LLC; 🇺🇸 Tallassee, Alabama, United States

East Valley Family Physicians; 🇺🇸 Chandler, Arizona, United States

HOPE Research Institute; 🇺🇸 Phoenix, Arizona, United States

Heartland Research Associates LLC; 🇺🇸 Arkansas City, Arkansas, United States

Lovelace Scientific Research, Inc.; 🇺🇸 Beverly Hills, California, United States

MED Investigations; 🇺🇸 Carmichael, California, United States

MED Investigations, Inc.; 🇺🇸 Fair Oaks, California, United States

Universal BioPharma Research, Inc.; 🇺🇸 Fresno, California, United States

Santa Barbara Clinical Research, Inc; 🇺🇸 Santa Barbara, California, United States

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