Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Phase 3CompletedNCT00171678

Novartis480 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Osteearthritis

Interventions

Diclofenac Topical Sodium Gel 1%DRUG

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Consumer Health Inc.

Parsippany, New Jersey, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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