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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00750243

Enrollment

120

Registered

2008-09-10

Start date

2008-09-30

Completion date

2009-04-30

Last updated

2010-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLT-NS001

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

DRUGNaprosyn®

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Assessment of GI mucosal injury by endoscopy	7 days

Secondary

Measure	Time frame
Comparison of naproxen PK at steady state	7.5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026