Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis - Full Text View

Purpose

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

Condition	Intervention	Phase
Tendonitis Bursitis	Drug: Ketoprofen Topical Patch 20%	Phase III

MedlinePlus related topics:

Bursitis

ChemIDplus related topics:

Ketoprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

Average pain intensity during daily activities

Secondary Outcome Measures:

Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep

Estimated Enrollment:	330
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females 18 years of age or older
Diagnosis of tendonitis or bursitis of the shoulder, elbow or knee
Meet pain entry criteria
Willing to discontinue use of any pain medication not provided by study

Exclusion Criteria:

Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
Have received corticosteroids in the 30 days preceding screening
Have a history or physical examination finding that is incompatible with safe participation in the study
Have a history or physical examination finding that is incompatible with study product use
Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
Are taking medications that may significantly affect renal function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426985

Locations


United States, Texas
	PPD
	Austin,, Texas, United States

Sponsors and Collaborators

Endo Pharmaceuticals

Investigators


Study Director:	PPD	PPD

More Information

Study ID Numbers:	EN3269-304
First Received:	January 24, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00426985
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

Tendonitis

Bursitis

Pain

Shoulder Pain

Elbow Pain

Knee Pain

Tendon Injury

Muscle, Bone and Cartilage Disorders

Study placed in the following topic categories:

Ketoprofen

Tendinopathy

Tendon Injuries

Muscular Diseases

Musculoskeletal Diseases

Shoulder Pain

Joint Diseases

Wounds and Injuries

Disorders of Environmental Origin

Pain

Bursitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00426985