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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.
 
ClinicalTrials.gov Identifier: NCT00640939
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : August 6, 2008
Sponsor:
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 18, 2008
First Posted Date  ICMJE March 21, 2008
Last Update Posted Date August 6, 2008
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2008)
Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: diclofenac sodium
    15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
    Other Name: diclofenac
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Topical diclofenac sodium patch
    Intervention: Drug: diclofenac sodium
  • Placebo Comparator: B
    Topical patch identical in appearance to active comparator
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2008)
308
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640939
Other Study ID Numbers  ICMJE DCF-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dan Levitt, MD, Cerimon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cerimon Pharmaceuticals
Collaborators  ICMJE PPD
Investigators  ICMJE
Study Director: Dan Levitt, MD Cerimon Pharmaceuticals
PRS Account Cerimon Pharmaceuticals
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP