Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IBU twice daily · 1 trial · 1 indication
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
IBU twice daily is a topical small molecule being studied for the treatment of ankle injuries, specifically ankle sprains. It is an investigational drug and is not approved by the FDA. The drug is applied twice daily and is being evaluated in a clinical trial setting.
IBU twice daily is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for ankle injuries.
IBU twice daily is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial has been completed, and the drug is still in clinical development as it undergoes further evaluation.
IBU twice daily has one completed Phase 3 clinical trial with the identifier NCT01945034, titled '5% Topical Ibuprofen (IBU) for Ankle Sprain'. This randomized, double-blind, placebo-controlled trial enrolled 304 participants in the United States, with a minimum age of 12 years.
IBU twice daily contains ibuprofen, a nonsteroidal anti-inflammatory drug. It is applied topically to the affected area to reduce inflammation and pain associated with ankle injuries. The drug is designed to deliver ibuprofen locally to the site of injury.