Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
This study has been completed.
Sponsor:
Cerimon Pharmaceuticals
Collaborator:
PPD
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00640939
First received: March 18, 2008
Last updated: August 5, 2008
Last verified: August 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: diclofenac sodium Drug: Matching Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cerimon Pharmaceuticals:
Primary Outcome Measures:
- Assess the efficacy of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the safety and tolerability of diclofenac in subjects with tendonitis or bursitis of the shoulder, elbow, or wrist. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 308 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dan Levitt, MD, Cerimon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00640939 History of Changes |
| Other Study ID Numbers: | DCF-003 |
| Study First Received: | March 18, 2008 |
| Last Updated: | August 5, 2008 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Cerimon Pharmaceuticals:
|
Tendonitis Bursitis |
Additional relevant MeSH terms:
|
Bursitis Tennis Elbow Tendinopathy Tenosynovitis Joint Diseases Musculoskeletal Diseases Arm Injuries Wounds and Injuries Muscular Diseases Tendon Injuries Diclofenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013