Trial | NCT00750243  Report issue

Title

Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation
A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    naproxen ...

  • Study Participants

    120
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.
Study Started
Sep 30
2008
Primary Completion
Feb 28
2009
Study Completion
Apr 30
2009
Last Update
Oct 06
2010
Estimate

Drug LT-NS001

1200 mg b.i.d. p.o. for 7.5 days

Drug Naprosyn®

500 mg b.i.d. p.o. for 7.5 days

A Experimental

B Active Comparator

Criteria 

Inclusion Criteria:

BMI 18-30 kg/m2
No NSAID's for 14 days prior to baseline endoscopy

Exclusion Criteria:

Pregnant/Nursing women
History of documented gastroduodenal ulcer
No Results Posted