Clinical trial NCT00640939: Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: 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
Keywords: Tendonitis
Bursitis
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2008-03-21
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
timeFrame: 14 days
Secondary outcomes:
measure: Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.
timeFrame: 14 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Cerimon Pharmaceuticals
name: Dan Levitt, MD
role: STUDY_DIRECTOR
References: