NCT00640939

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

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 Bursitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Cerimon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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 description

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.

Conditions

• Rotator Cuff Tendonitis
• Bicipital Tendonitis
• Subdeltoid Bursitis of the Shoulder
• Subacromial Bursitis of the Shoulder
• Medial Epicondylitis of the Elbow
• Lateral Epicondylitis of the Elbow
• DeQuervain's Tenosynovitis of the Wrist

Interventions

Type	Name	Description
DRUG	diclofenac sodium	15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
DRUG	Matching Placebo	Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-04-01
• Completion: 2008-06-01
• First posted: 2008-03-21
• Last updated: 2008-08-06

Locations

1 site across 1 country: United States