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

Phase 3

Terminated

• Conditions: Acute Pain From Ankle Sprain or Strain
• Interventions: Drug: Placebo; Drug: K-103-IP

• Registration Number: NCT02089425
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Study Start: 2014-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Disposition First Submitted: 2015-04-14
• Disposition First Submitted QC: 2015-04-14
• Disposition First Posted: 2015-05-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo patch: 0% indomethacin
K-103-IP	K-103-IP	K-103-IP: 0.5% indomethacin

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference(SPID) 0-72	72 Hours

Secondary Outcome Measures

Name	Time	Method
Mean change from Baseline in pain intensity difference (PID)	168 Hours