Sprain Clinical Trial
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
NCT number | NCT00351104 |
Other study ID # | EN3269-301 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | March 2007 |
Verified date | February 2020 |
Source | APR Applied Pharma Research s.a. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | PPD | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
APR Applied Pharma Research s.a. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average pain intensity during daily activities | |||
Secondary | 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 |
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