Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain

Phase 2 Completed 394 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.

Timeline

Start: 2012-04-10
Primary completion: 2012-09-13
Completion: 2012-09-13

Outcome

Met primary endpoint

paper All active treatments were superior to placebo for SPRID[4]0-8 (all p < 0.001) PMID 32506309 ↗

Publications

Kellstein D, Leyva R. Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study. Drugs R D. 2020 Sep;20(3):237-247. doi: 10.1007/s40268-020-00310-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	500 mg	—
Subject	Ibuprofen	Small molecule	200 mg	—
Subject	Ibuprofen	Small molecule	250 mg	—
Subject	Ibuprofen	Small molecule	300 mg	—
Subject	Ibuprofen	Small molecule	400 mg	—

Indications

No indication recorded.