Clinical Trial: Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Tendonitis or The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.

The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Detailed Summary: Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
Sponsor: Cerimon Pharmaceuticals

Current Primary Outcome: Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ]

Original Secondary Outcome: Same as current

Information By: Cerimon Pharmaceuticals

Dates:
Date Received: March 18, 2008
Date Started: December 2007
Date Completion:
Last Updated: August 5, 2008
Last Verified: August 2008