Status:
COMPLETED
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Lead Sponsor:
Cerimon Pharmaceuticals
Collaborating Sponsors:
PPD Development, LP
Conditions:
Rotator Cuff Tendonitis
Bicipital Tendonitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 stu...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00640939
Start Date
December 1 2007
End Date
June 1 2008
Last Update
August 6 2008
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744