Phase 4
N=270
Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief
Ankle Sprain
Bottom Line
View on ClinicalTrials.gov: NCT01957215 ↗Enrolled (actual)
270
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Sum of Pain Intensity Difference (SPID)1-3 Days — 3.981; 3.264 Score on scale — p=0.0201
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Indomethacin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference (SPID)1-3 Days |
3.981; 3.264 | 0.0201 sig |
| SECONDARY Pain Relief Score (PRS) on Movement Over Time |
0.24; 0.21; 0.40; 0.42; 0.58; 0.53 | — |
| SECONDARY NRS for Pain on Movement Over Time |
6.90; 6.89; 6.85; 6.86; 6.55; 6.63 | — |
| SECONDARY Change From Baseline in NRS at Rest |
-3.581; -3.194 | — |
| SECONDARY Time to Onset of Pain Relief |
0.168; 0.208 | — |
| SECONDARY Assessment of Sum of Pain Intensity Difference (SPID) on Movement |
1.402; 1.169; 17.62; 15.82 | — |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement |
2.594; 2.099; 7.025; 5.695; 28.85; 25.43 | — |
| SECONDARY Total Pain Relief (TOTPAR) on Movement |
1.197; 0.935; 3.057; 2.44; 11.27; 9.649 | — |
| SECONDARY Patients' Global Assessment to Treatment |
2.7; 2.2 | — |
| SECONDARY Rate of Rescue Medication Use |
4; 7 | — |
| SECONDARY Time to First Dose of Rescue Medication Use |
0.198; 0.681 | — |
| SECONDARY Total Dose of Rescue Medication Use |
3; 4 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01957215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.