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OpenTrials
Completed

NCT Number: NCT00171691

Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases 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

  • Osteoarthritis 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. Incidence of treatment-emergent adverse events

  2. Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary outcomes

  1. Incidence of serious treatment-emergent adverse events

  2. Number of patients who discontinued study medication due to a treatment-emergent adverse event

  3. WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
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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