Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

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

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Drug: diclofenac sodium; Drug: Matching Placebo

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: Interventional
• Enrollment (Actual): 308
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Topical diclofenac sodium patch	Drug: diclofenac sodium; 15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily; Other Names: diclofenac
Placebo Comparator: B; Topical patch identical in appearance to active comparator	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 Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist.	14 days

Collaborators and Investigators

• Sponsor: Cerimon Pharmaceuticals
• Collaborators: PPD
• Investigators: Study Director: Dan Levitt, MD, Cerimon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): August 6, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Bursitis; Tendonitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arm Injuries; Rotator Cuff Injuries; Tendinopathy; Tennis Elbow; Bursitis; Tenosynovitis; Elbow Tendinopathy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: DCF-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No