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

A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426621

Enrollment

420

Registered

2007-01-25

Start date

2006-11-30

Completion date

2007-06-30

Last updated

2007-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium

Brief summary

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

Interventions

DRUGDiclofenac Sodium Gel

4 grams per knee, 4 times per day, for 12 weeks

DRUGPlacebo

4 grams per knee, 4 times per day, for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026