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Completed

NCT Number: NCT00171665

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alabama Clinical Therapeutics, Birmingham, 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.

Key Inclusion criteria:

  • Osteoarthritis of the hand

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. OA pain intensity in target hand at Week 4 and 6

  2. Total AUSCAN score in target hand at Week 4 and 6

  3. Global rating of disease activity by patient at Week 4 and 6

Secondary outcomes

  1. OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8

  2. AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8

  3. OA pain intensity in target hand 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
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Apr 14, 2015

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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