Diclofenac Patch for Treatment of Mild to Moderate Tendon... | NCT00640939

Studies
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

NCT00640939

Sponsor

Cerimon Pharmaceuticals

Status

Completed

Last Update Posted

Aug 6, 2008Estimated

Enrollment

308Actual

Phase

Phase 2Phase 3

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

Interventions

diclofenac sodium
Matching Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2008

Last Update Posted Date

Aug 6, 2008Estimated

Name	Class
PPD Development, LP	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
diclofenac sodium	Drug	15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily	A

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000070636	Rotator Cuff Injuries
D052256	Tendinopathy
D002062	Bursitis

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals