An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

Kowa Research Institute, Inc.0 sites384 target enrollmentApril 2014

ConditionsAcute Pain From Ankle Sprain or Strain

InterventionsK-103-IP Placebo

DrugsK-103-IP Placebo

Overview

Phase: Phase 3
Intervention: K-103-IP
Conditions: Acute Pain From Ankle Sprain or Strain
Sponsor: Kowa Research Institute, Inc.
Enrollment: 384
Primary Endpoint: Sum of Pain Intensity Difference(SPID) 0-72
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kowa Research Institute, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must provide informed consent before any study specific evaluation is performed.
•Subject is male or female aged 18 to 70 years, inclusive.
•Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
•Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.

Exclusion Criteria

•Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
•Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
•Subject has received topical analgesic medication within 24 hours before the Screening visit.
•Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.