NCT01957215

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

A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch Over Placebo in Ankle Sprain Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Ankle Sprain

Interventions

Type	Name	Description
DRUG	Indomethacin	Topical indomethacin
DRUG	Placebo	Placebo patch

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-10-08
• Last updated: 2015-06-15
• Results posted: 2015-06-15

Locations

15 sites across 1 country: China