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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source APR Applied Pharma Research s.a.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.


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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketoprofen Topical Patch 20%


Locations

Country Name City State
United States PPD Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
APR Applied Pharma Research s.a.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Completed NCT00671320 - A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle Phase 4
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Completed NCT00601471 - Effects of Proximal and Distal Tibiofibular Joint Manipulation on Lower Extremity Muscle Activation, Ankle Range of Motion, and Functional Outcome Scores in Individuals With Chronic Ankle Instability N/A
Withdrawn NCT01223053 - Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury Phase 3