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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Pain From Ankle Sprain or Strain

In brief

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.

Key facts

Study ID

NCT02089425

Run by

Kowa Research Institute, Inc.

People needed

384

Starts

2014-04-01

Expected to finish

2014-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — El Cajon, California, United States
• Study site — Encinitas, California, United States
• Study site — Los Angeles, California, United States
• Study site — Ventura, California, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Doral, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Oldsmar, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Overland Park, Kansas, United States
• Study site — Owensboro, Kentucky, United States
• Study site — Towson, Maryland, United States
• Study site — Rochester, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Great Falls, Montana, United States

Full record on ClinicalTrials.gov

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