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

Kowa

Status and phase

Terminated

Phase 3

Conditions

Acute Pain From Ankle Sprain or Strain

Treatments

Drug: Placebo

Drug: K-103-IP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02089425

K-103-IP-3.01US

Details and patient eligibility

About

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.

Enrollment

384 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.