Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation

Phase 1 Completed 120 enrolled Logical Therapeutics

RandomizedParallel-groupQuadruple-blind

Summary

The purpose of this study is to compare naproxen plasma levels and gastroduodenal mucosal injury after administration of LT-NS001 as compared to Naprosyn in subjects age 45-70.

Timeline

Start: 2008-09
Primary completion: 2009-02
Completion: 2009-04

Publications

Goldstein JL, Jungwirthova A, David J, Spindel E, Bouchner L, Pesek F, Searle S, Skopek J, Grim J, Ulc I, Sewell KL. Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study. Aliment Pharmacol Ther. 2010 Nov;32(9):1091-101. doi: 10.1111/j.1365-2036.2010.04442.x. Epub 2010 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NAPROXEN ETEMESIL	Small molecule	1200 mg	Oral
Comparator	Naproxen	Small molecule	500 mg	Oral

Indications

No indication recorded.