Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1)

Summary

This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

Timeline

Start

2011-11

Primary completion

2012-06

Completion

2012-06

Outcome

Met primary endpoint

paper The primary objective of the study was met, demonstrating that etoricoxib 120 mg qd was non-inferior to ibuprofen 600 mg qid; PMID 24960147 ↗

paper further, etoricoxib was statistically superior to ibuprofen 600 mg qid according to the primary endpoint (TOPAR6) PMID 24960147 ↗

Publications

• Results Yu Q, Zhu X, Zhang X, Zhang Y, Li X, Hua Q, Chang Q, Zou Q, Di W, Yao Y, Yu W, Liu J, Mehta A, Yan L. Etoricoxib in the treatment of primary dysmenorrhea in Chinese patients: a randomized controlled trial. Curr Med Res Opin. 2014 Sep;30(9):1863-70. doi: 10.1185/03007995.2014.925437. Epub 2014 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etoricoxib	Small molecule	120 mg	Oral
Subject	Ibuprofen	Small molecule	600 mg	—
Background	Acetaminophen	Small molecule	250 mg	—
Background	Caffeine	Small molecule	50 mg	—
Background	PROPYPHENAZONE	Small molecule	150 mg	—

Indications