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Completed

NCT Number: NCT00171678

Efficacy and Safety of Diclofenac Sodium Gel 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

Osteearthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Consumer Health Inc.

Parsippany, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diclofenac Topical Sodium Gel 1%

Drug

Primary outcomes

  1. WOMAC pain score in target knee at Week 12

  2. WOMAC physical function score in target knee at Week 12

  3. Global rating of disease activity by patient at Week 12

Secondary outcomes

  1. WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8

  2. 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

  3. Pain on movement in target knee and use of rescue medication recorded in diary

  4. Global evaluation of treatment at final visit

  5. Treatment responder rate according to OARSI criteria

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Apr 23, 2012

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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