Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01945034 | 5% Topical Ibuprofen (IBU) for Ankle Sprain | PHASE3 | COMPLETED | 304 | — | — | Nov 1, 2013 | Feb 1, 2015 | May 26, 2016 | 19 | United States |
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.
PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.
| Arm | Type | Description |
|---|---|---|
| Topical IBU twice daily | EXPERIMENTAL | - |
| Placebo twice daily | PLACEBO_COMPARATOR | - |
| Topical IBU three times daily | EXPERIMENTAL | - |
| Placebo three times daily | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Topical IBU twice daily | DRUG | Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days |
| Placebo twice daily | DRUG | Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days |
| Topical IBU three times daily | DRUG | Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days |
| Placebo three times daily | DRUG | Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days |
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