Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640939
First received: March 18, 2008
Last updated: August 5, 2008
Last verified: August 2008
  Purpose

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640939

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

No publications provided

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:
Tendonitis
Bursitis

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

ClinicalTrials.gov processed this record on April 22, 2014