Phase 3 N=304 Randomized Triple-blind Treatment

5% Topical Ibuprofen (IBU) for Ankle Sprain

Ankle Injuries

Bottom Line

View on ClinicalTrials.gov: NCT01945034 ↗

Enrolled (actual)

304

Serious AEs

0.3%

Results posted

May 2016

Primary outcome: Primary: Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3) — 188.9; 173.6; 165.9 units on a scale — p=0.190

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Topical IBU twice daily (Drug); Placebo twice daily (Drug); Topical IBU three times daily (Drug); Placebo three times daily (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)	188.9; 173.6; 165.9	0.190
PRIMARY Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)	46.9; 41.1; 42.1	0.426
SECONDARY Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)	44.7; 29.4; 34.7	0.072
SECONDARY Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10	0.7; 0.7; 0.6; 1.8; 1.7; 1.6	0.305
SECONDARY Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10	0.7; 0.7; 0.8; 1.8; 2.0; 2.0	0.354
SECONDARY Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points	1.3; 0.7; 1.2; 1.5; 1.1; 1.4	0.771
SECONDARY Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3	10.4; 6.6; 8.4; 11.7; 9.4; 9.9	0.166
SECONDARY Sum of Pain Intensity Difference Scores at Rest Over 3 Days	177.6; 131.1; 139.0	0.021 sig
SECONDARY Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days	472.5; 396.6; 384.8; 516.4; 507.7; 470.4	0.021 sig
SECONDARY Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10	1.0; 0.9; 0.7; 2.1; 2.1; 2.1	0.042 sig
SECONDARY Participant's Global Assessment of Medication at End of Study	3.8; 4; 4	—
SECONDARY Time to First Perceptible Relief and Meaningful Relief	12.9; 36.4; 22.7; 41.6; NA; 72.6	0.016 sig
SECONDARY Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose	—	—
SECONDARY Number of Doses of Rescue Medication Used During the First 7 Days of Dosing	1.7; 0.6; 1.2	0.479
SECONDARY Percentage of Participants Taking Rescue Medication	28.4; 18.8; 25.7	—

Summary

This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical placebo for the relief of pain associated with a first or second degree ankle sprain. Both twice daily and three times daily regimens will be evaluated.

Eligibility Criteria

Inclusion Criteria

First or second degree ankle sprain within 48 hours of first dose of study medication
Medically cleared to participate

Exclusion Criteria

Similar injury of same joint within last 6 months
Requires bed rest, surgery, or over-the-counter or prescription analgesics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01945034). 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.