Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

This study has been completed.
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: March 18, 2008
Last updated: August 5, 2008
Last verified: August 2008

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.

Condition Intervention Phase
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
Drug: diclofenac sodium
Drug: Matching Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Bursitis

Resource links provided by NLM:

Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 308
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Topical diclofenac sodium patch
Drug: diclofenac sodium
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Other Name: diclofenac
Placebo Comparator: B
Topical patch identical in appearance to active comparator
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
Other Name: placebo

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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years to 75 years of age
  • Onset of painful upper extremity tendonitis or bursitis, no more than 21 days prior to study entry
  • Eligible diagnoses are rotator cuff tendonitis, bicipital tendonitis or subdeltoid/subacromial bursitis of the shoulder, medial or lateral epicondylitis of the elbow, and DeQuervain's tenosynovitis of the wrist
  • Spontaneous pain with motion or resisted motion and tenderness to palpation over the involved tendon(s), bursa, or epicondyle
  • Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)

Exclusion Criteria:

  • Aspirin, or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (see Appendix B: for table of NSAIDs)
  • Opioid use within 3 days prior to study entry
  • Topical treatment, other than local ice or heat, applied to the painful region within 3 days prior to study entry
  • History of peptic ulcer disease within 1 year prior to study entry, any history of gastrointestinal bleeding, or coagulation disorder
  • A history of, or evidence for underlying articular disease such as osteoarthritis, rheumatoid arthritis, gout, or pseudogout (calcium pyrophosphate deposition disease)
  • Clinically significant and poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
  • A history of hypersensitivity to diclofenac or diclofenac-containing products
  • A history of intolerance to acetaminophen (rescue medication in this trial)
  • A history of skin sensitivity to adhesives (e.g. adhesive tape)
  • Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00640939

United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerimon Pharmaceuticals
Study Director: Dan Levitt, MD Cerimon Pharmaceuticals
  More Information

Responsible Party: Dan Levitt, MD, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00640939     History of Changes
Other Study ID Numbers: DCF-003 
Study First Received: March 18, 2008
Last Updated: August 5, 2008
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Cerimon Pharmaceuticals:

Additional relevant MeSH terms:
Tennis Elbow
Arm Injuries
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016