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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Ankle Sprain

Treatments

Drug: Placebo

Drug: Indomethacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01957215

202177

RH01778 (Other Identifier)

Details and patient eligibility

About

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

Full description

Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which reduces pain, fever, stiffness and swelling in acute skeletal musculature injuries involving joints. However, oral Indomethacin formulations predisposes for some systemic side effects. To avoid the systemic side effects of oral Indomethacin, a topical Indomethacin formulations have been developed and approved in some countries as an Over the counter product. Present study is to investigate the efficacy of the Indomethacin patch in pain relief of ankle sprain in adult patients.

Enrollment

270 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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