Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients, compared to a placebo patch

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Collaborator: Rundo International Pharmaceutical Research & Development Co.,Ltd.
• Treatments: Indomethacin

Criteria

Inclusion Criteria:

• Participant with Grade I or Grade II acute sprain of the lateral ankle within 24 hours before screening visit

• Participant with self-assessed pain intensity score after movement (5 steps) at the site of the ankle sprain that is >= 5 as measured on a 0-10 NRS rating.

• Participant with a peri-malleolar edema (sub-malleolar perimeter difference of >=20mm between injured and uninjured ankle)

Exclusion Criteria:

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

• Participant who had medication that could interfere with the subject's perception of pain since experiencing ankle sprain.

• Pregnancy , Breast Feeding and Substance Abuse