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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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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

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Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Indomethacin patch

Indomethacin patch to be applied on the sprained ankle twice a day (BID).

Group Type EXPERIMENTAL

Indomethacin

Intervention Type DRUG

Topical indomethacin

Placebo patch

Placebo patch to be applied on the sprained ankle BID.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo patch

Interventions

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Indomethacin

Topical indomethacin

Intervention Type DRUG

Placebo

Placebo patch

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Changzhou NO.2 People's Hospital

Changzhou, Jiangsu, China

Site Status

Changzhou NO.2 People?s Hospital

Changzhou, Jiangsu, China

Site Status

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Site Status