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

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Diclofenac Sodium Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00426621

VOSG-PN-316

Details and patient eligibility

About

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

Enrollment: 420 patients

Sex: All

Ages: 35+ years old

Volunteers: No 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/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Diclofenac Sodium Gel

2

Placebo Comparator group

Treatment:

Drug: Placebo