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

NCT ID: NCT00750243

Last Updated: 2010-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

LT-NS001

Intervention Type DRUG

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

B

Group Type ACTIVE_COMPARATOR

Naprosyn®

Intervention Type DRUG

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

Interventions

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LT-NS001

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

Intervention Type DRUG

Naprosyn®

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Logical Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Logical Therapeutics

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20804454 (View on PubMed)

Other Identifiers

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LT-NS001-002

Identifier Type: -

Identifier Source: org_study_id