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Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

This study has been completed.
Information provided by:
Endo Pharmaceuticals Identifier:
First received: June 30, 2006
Last updated: August 13, 2008
Last verified: August 2008
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.

Condition Intervention Phase
Sprain Strain Drug: Ketoprofen Topical Patch 20% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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 Grade 1 or Grade 2 Ankle Sprain or Strain

Resource links provided by NLM:

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; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication

Enrollment: 200
Study Start Date: June 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (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 Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, 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. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females 18 years of age or older
  • Diagnosis of Grade I or Grade II ankle sprain or strain
  • Meet pain entry criteria
  • Willing to discontinue use of any pain medication not provided as part of the study

Exclusion Criteria:

  • Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
  • 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
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Please refer to this study by its identifier: NCT00351104

United States, Texas
Austin, Texas, United States, 78704
Sponsors and Collaborators
Endo Pharmaceuticals
Principal Investigator: PPD PPD Austin, TX
  More Information

Responsible Party: Stephen McMorn, Endo Pharmaceuticals Identifier: NCT00351104     History of Changes
Other Study ID Numbers: EN3269-301
Study First Received: June 30, 2006
Last Updated: August 13, 2008

Keywords provided by Endo Pharmaceuticals:
Ankle Pain
Muscle, Bone and Cartilage Disorders

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017