Clinical Study to Evaluate Effect on QT/QTc Interval After Multiple Dose of Celecoxib

Summary

This study is conducted to evaluate effect on QT/QTc Interval after multiple dose of celecoxib among healthy adult volunteers. It is randomized, open-label, negative and postive control, and crossover study. Volunteers will be mainly checked up through ECG to find out changes of QT/QTc interval during the study.

Timeline

Start

2017-06-30

Primary completion

2018-05-25

Completion

2018-05-25

Outcome

Met primary endpoint

paper The largest time-matched mean effects of celecoxib on the QTcI and QTcF were <5 ms PMID 31564512 ↗

paper the upper bounds of the 1-sided 95% CIs of those values did not exceed 10 ms. PMID 31564512 ↗

Publications

• Kim S, Lee H, Ko JW, Kim JR. Effects of Celecoxib on the QTc Interval: A Thorough QT/QTc Study. Clin Ther. 2019 Nov;41(11):2204-2218. doi: 10.1016/j.clinthera.2019.09.004. Epub 2019 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	400 mg	Oral
Subject	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.