Trial Outcomes & Findings for Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief (NCT NCT01957215)

Results Overview

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"

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

270 participants

Primary outcome timeframe

Baseline (Day 1) to Day 3

Results posted on

2015-06-15

Participant Flow

The study was conducted across multiple sites in China.

Participant milestones

Participant milestones
Measure	Indomethacin Patch 0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).	Placebo Patch Placebo patch was applied on the sprained ankle BID.
Overall Study STARTED	135	135
Overall Study COMPLETED	122	123
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Indomethacin Patch 0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).	Placebo Patch Placebo patch was applied on the sprained ankle BID.
Overall Study Adverse Event	2	2
Overall Study Lost to Follow-up	3	3
Overall Study Protocol Violation	1	2
Overall Study Withdrawal by Subject	7	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indomethacin Patch n=135 Participants Indomethacin patch was applied on the sprained ankle BID	Placebo Patch n=135 Participants Placebo patch was applied on the sprained ankle BID	Total n=270 Participants Total of all reporting groups
Age, Continuous	37.7 Years STANDARD_DEVIATION 12.73 • n=5 Participants	35.6 Years STANDARD_DEVIATION 12.29 • n=7 Participants	36.6 Years STANDARD_DEVIATION 12.53 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	62 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) to Day 3

Population: Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement

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"

Outcome measures

Outcome measures
Measure	Indomethacin Patch n=135 Participants Indomethacin patch was applied on the sprained ankle BID	Placebo Patch n=135 Participants Placebo patch was applied on the sprained ankle BID
Sum of Pain Intensity Difference (SPID)1-3 Days	3.981 Score on scale Standard Error 0.2163	3.264 Score on scale Standard Error 0.2163

SECONDARY outcome

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

Population: Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.

PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.