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

NCT01957215 | Completed Phase 4 Results

• 2 other identifiers: 202177RH01778
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 15

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

Conditions

Ankle Sprain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID)1-3 Days

  SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1). Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents "No" and 10 represents the "worst possible pain"

  Baseline (Day 1) to Day 3

Secondary Outcomes (11)

• Pain Relief Score (PRS) on Movement Over Time

  30 minutes (mins) to 144 hours (hrs) post treatment

• NRS for Pain on Movement Over Time

  30 mins to 144 hr post treatment

• Change From Baseline in NRS at Rest

  Baseline (Day 1) to Day 7

• Time to Onset of Pain Relief

  Baseline (Day 1) to Day 3

• Assessment of Sum of Pain Intensity Difference (SPID) on Movement

  Baseline (Day 1) to Day 7

Study Arms (2)

Indomethacin patch

EXPERIMENTAL

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

Drug: Indomethacin

Placebo patch

PLACEBO COMPARATOR

Placebo patch to be applied on the sprained ankle BID.

Drug: Placebo

Interventions

Indomethacin DRUG

Topical indomethacin

Indomethacin patch

Placebo DRUG

Placebo patch

Placebo patch

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Rundo International Pharmaceutical Research & Development Co.,Ltd.: collaborator

Study Sites (15)

Changzhou NO.2 People's Hospital

Changzhou, Jiangsu, 213003, China

Location

Changzhou NO.2 People?s Hospital

Changzhou, Jiangsu, 213003, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Ruijin Hospital Luwan Branch

Shanghai, Shanghai Municipality, 200020, China

Location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai Xuhui Centre Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai Tenth People?s Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai Tenth Peoples Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Shanghai First People?s Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Shanghai First Peoples Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 15, 2015
• Results First Posted: June 15, 2015

Record last verified: 2015-04

Locations

CN (15)