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Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

NCT00640939 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2008-08-06

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Cerimon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Dan Levitt, MD · Cerimon Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-04-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640939 on ClinicalTrials.gov