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Completed

NCT Number: NCT00426621

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

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

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Key information

Conditions

Osteoarthritis of the Knee Arthralgia Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Coastal Clinical Research Inc, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac Sodium Gel

Drug

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

Placebo

Drug

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

Primary outcomes

  1. pain in the target knee (WOMAC pain index);

  2. functional capacity in the target knee (WOMAC function index); and

  3. global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary outcomes

  1. Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:

  2. Low pain intensity in either knee; and

  3. Low functional impairment in either knee.

  4. Safety of Diclofenac Sodium Gel 1% assessed by:

  5. monitoring adverse events; and

  6. laboratory evaluations.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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.

Important dates

Study start
2006
Study completion
2007
First posted
Jan 25, 2007
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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