Clinical trial NCT01957215: Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
Official title: A Clinical Study to Assess the Efficacy of Pain Relief of Topical Indomethacin Patch Over Placebo in Ankle Sprain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Rundo International Pharmaceutical Research & Development Co.,Ltd.
First posted: 2013-10-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID)1-3 Days
timeFrame: Baseline (Day 1) to Day 3
Secondary outcomes:
measure: Pain Relief Score (PRS) on Movement Over Time
timeFrame: 30 minutes (mins) to 144 hours (hrs) post treatment
measure: NRS for Pain on Movement Over Time
timeFrame: 30 mins to 144 hr post treatment
measure: Change From Baseline in NRS at Rest
timeFrame: Baseline (Day 1) to Day 7
measure: Time to Onset of Pain Relief
timeFrame: Baseline (Day 1) to Day 3
measure: Assessment of Sum of Pain Intensity Difference (SPID) on Movement
timeFrame: Baseline (Day 1) to Day 7
measure: Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement
timeFrame: Baseline (Day 1) to Day 7
measure: Total Pain Relief (TOTPAR) on Movement
timeFrame: Baseline (Day 1) to Day 7
measure: Patients' Global Assessment to Treatment
timeFrame: Baseline (Day 1) to Day 14
measure: Rate of Rescue Medication Use
timeFrame: Baseline (Day 1) to Day 14
measure: Time to First Dose of Rescue Medication Use
timeFrame: Baseline (Day 1) to Day 14
measure: Total Dose of Rescue Medication Use
timeFrame: Baseline (Day 1) to Day 14
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou NO.2 People's Hospital
state: Jiangsu
city: Changzhou
country: China
facility: Changzhou NO.2 People?s Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital Luwan Branch
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Xuhui Centre Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People?s Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth Peoples Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People?s Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Peoples Hospital
state: Shanghai
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: