Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

NCT00640939 | Completed Phase 2

• 1 other identifier: DCF-003
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

  14 days

Secondary Outcomes (1)

• Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.

  14 days

Study Arms (2)

A

ACTIVE COMPARATOR

Topical diclofenac sodium patch

Drug: diclofenac sodium

B

PLACEBO COMPARATOR

Topical patch identical in appearance to active comparator

Drug: Matching Placebo

Interventions

diclofenac sodium DRUG

15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily

Also known as: diclofenac

A

Matching Placebo DRUG

Matching placebo patch, containing identical constituents to active patch except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily

Also known as: placebo

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerimon Pharmaceuticals: lead
• PPD Development, LP: collaborator

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Tendinopathy; Bursitis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Musculoskeletal Diseases; Joint Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dan Levitt, MD

  Cerimon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 6, 2008

Record last verified: 2008-08

Locations

US (1)