Study Of Celecoxib In Healthy Subjects

Phase 4 Completed 190 enrolled Viatris Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.

Timeline

Start: 2009-11
Primary completion: 2010-04
Completion: 2010-04

Outcome

Met primary endpoint

paper Incidence of GD ulcers was 1.4%, 27.6% and 2.7% in the celecoxib, loxoprofen and placebo groups respectively (P < 0.0001 in favour of the celecoxib group); PMID 23216412 ↗

paper Celecoxib 100 mg b.d. was superior to loxoprofen 60 mg t.d.s. regarding the incidence of gastro-duodenal endoscopic ulcers over 2 weeks. PMID 23216412 ↗

Publications

Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	100 mg	—
Comparator	Loxoprofen	Small molecule	60 mg	—

Indications

No indication recorded.