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Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

NCT ID: NCT00640939

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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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

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Tendonitis Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Topical diclofenac sodium patch

Group Type ACTIVE_COMPARATOR

diclofenac sodium

Intervention Type DRUG

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

B

Topical patch identical in appearance to active comparator

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

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

Interventions

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diclofenac sodium

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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diclofenac placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Cerimon Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Cerimon Pharmaceuticals, Inc.

Principal Investigators

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Dan Levitt, MD

Role: STUDY_DIRECTOR

Cerimon Pharmaceuticals

Locations

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PPD

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DCF-003

Identifier Type: -

Identifier Source: org_study_id