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

Acute Pain From Ankle Sprain or Strain Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02089425
• Other study ID #: K-103-IP-3.01US
• Status: Terminated
• Phase: Phase 3
• First received: March 14, 2014
• Last updated: March 2, 2017
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2017
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 384
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain From Ankle Sprain or Strain
• Ankle Injuries
• Sprains and Strains

Intervention

Drug:
• K-103-IP

• Placebo
Placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity Difference(SPID) 0-72		72 Hours
Secondary	Mean change from Baseline in pain intensity difference (PID)		168 Hours