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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Naprosyn®; Drug: LT-NS001

• Registration Number: NCT00750243
• Lead Sponsor: Logical Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-10
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Disposition First Submitted: 2010-09-17
• Status Verified: 2010-10
• Disposition First Submitted QC: 2010-10-04
• Last Update Submitted: 2010-10-04
• Disposition First Posted: 2010-10-06
• Last Update Posted: 2010-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Naprosyn®	-
A	LT-NS001	-

Primary Outcome Measures

Name	Time	Method
Assessment of GI mucosal injury by endoscopy	7 days

Secondary Outcome Measures

Name	Time	Method
Comparison of naproxen PK at steady state	7.5 days

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States