Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Information source: Cerimon Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: 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: diclofenac sodium (Drug); Matching Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Cerimon Pharmaceuticals Official(s) and/or principal investigator(s):
Mary Jean Stempien, MD, Study Director, Affiliation: Cerimon Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
Secondary outcome: Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
PPD, Austin, Texas 78744, United States
Additional Information
Starting date: December 2007
Ending date: June 2008
Last updated: June 18, 2008
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