Conditions: Ankle Sprain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 270
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Indomethacin patch to be applied on the sprained ankle twice a day (BID). arm 2: Placebo patch to be applied on the sprained ankle BID.

Interventions: intervention 1: Indomethacin intervention 2: Placebo
Intervention descriptions: intervention 1: Topical indomethacin intervention 2: Placebo patch

Protocol document: