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Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640939
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : August 6, 2008
Information provided by:
Cerimon Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bursitis

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00640939

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United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Cerimon Pharmaceuticals
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Study Director: Dan Levitt, MD Cerimon Pharmaceuticals
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Responsible Party: Dan Levitt, MD, Cerimon Pharmaceuticals, Inc. Identifier: NCT00640939    
Other Study ID Numbers: DCF-003
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: August 2008
Keywords provided by Cerimon Pharmaceuticals:
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Rotator Cuff Injuries
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Joint Diseases
Shoulder Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action