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

APR Applied Pharma Research

Status and phase

Completed

Phase 3

Conditions

Sprain

Strain

Treatments

Drug: Ketoprofen Topical Patch 20%

Study type

Interventional

Funder types

Other

Identifiers

NCT00351104

EN3269-301

Details and patient eligibility

About

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

Full 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

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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