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Also known as IBU BID
IBU · 2 trials · 1 indication
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Participants were asked to complete one preacher curl, using the arm that was exercised earlier to stimulate muscle soreness on movement (MSM). Upon completion of preacher curl, participants were asked to rate their degree of MSM, using an 11 point scale ranging from 0 to 10, where 0=not sore and 10=extremely sore, higher score=more severity. Change from baseline in the time-weighted sum of MSM over 0-24 hours was derived as the MSM change from baseline multiplied by time elapsed since the previous assessment and summed over all assessments from Hour 0 to Hour 24 (range: -96 to 240, higher score indicates better response).
| Arm | Type | Description |
|---|---|---|
| Fixed Dose Combination(FDC) IBU/APAP 250 mg/500 mg | ACTIVE_COMPARATOR | FDC IBU/APAP 250 mg/500 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Ibuprofen 5% topical gel BID | EXPERIMENTAL | IBU BID (Treatment A) |
| Placebo topical gel BID | PLACEBO_COMPARATOR | Placebo BID (Treatment B) |
| Ibuprofen 5% topical gel TID | EXPERIMENTAL | IBU TID (Treatment C) |
| Placebo topical gel TID | PLACEBO_COMPARATOR | Placebo TID (Treatment D) |
| Name | Type | Description |
|---|---|---|
| FDC IBU/APAP 250 mg/500 mg | DRUG | FDC IBU/APAP 250 mg/500 mg |
| Placebo | DRUG | Placebo |
| IBU BID | DRUG | 10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days |
| Placebo BID | DRUG | 10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days |
| IBU TID | DRUG | 10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days |
| Placebo TID | DRUG | 10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days |
Inclusion Criteria 1. Males and females 18 years to 40 years of age (inclusive). 2. Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction. 3. Subject must have at least moderate pain on the 4 point c...
IBU is an investigational fixed-dose combination of ibuprofen and acetaminophen being studied for the treatment of pain. It is being developed by Pfizer, Inc. and is in Phase 3 clinical development. The program has evaluated IBU in pain settings including post-surgical dental pain and delayed onset muscle soreness.
IBU is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating IBU, including the Phase 3 studies in post-surgical dental pain and delayed onset muscle soreness.
IBU is in Phase 3 clinical development. Both of its registered trials were Phase 3 studies, and both have been completed. IBU is an investigational product and is not approved for commercial use. The completed trials enrolled a total of 328 participants across the two studies.
IBU has been studied in two completed Phase 3 trials. NCT02837952 evaluated IBU 250 mg/APAP 500 mg in post-surgical dental pain and enrolled 123 participants in the United States. NCT01794923 evaluated topical ibuprofen for delayed onset muscle soreness and enrolled 205 participants in the United States. Both were randomized, double-blind, placebo-controlled studies.