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Also known as Topical IBU three times daily
IBU three times 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 three times daily is a topical ibuprofen formulation applied three times a day, being developed by Pfizer, Inc. (PFE) for ankle injuries. It is a small molecule therapy in Phase 3 clinical development. The treatment is designed for topical application to the affected area.
IBU three times daily is being developed for the treatment of ankle injuries, specifically ankle sprains. It is intended to provide localized anti-inflammatory and analgesic effects when applied topically three times daily. The Phase 3 trial enrolled patients with ankle injuries.
IBU three times daily is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical program evaluating this topical ibuprofen formulation for ankle injuries.
IBU three times daily is in Phase 3 clinical development. The program includes one completed Phase 3 trial. It is an investigational product and has not been approved by the FDA for any indication.
IBU three times daily has been evaluated in one completed Phase 3 clinical trial, NCT01945034, titled "5% Topical Ibuprofen (IBU) for Ankle Sprain." The trial enrolled 304 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, IBU three times daily is also known as topical IBU three times daily. Both names refer to the same investigational topical ibuprofen formulation developed by Pfizer for ankle injuries.