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Completed

NCT Number: NCT00750243

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

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.

Completed

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Key information

Conditions

Healthy

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LT-NS001

Drug

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

Naprosyn®

Drug

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

Primary outcomes

  1. Assessment of GI mucosal injury by endoscopy

    Time frame: 7 days

Secondary outcomes

  1. Comparison of naproxen PK at steady state

    Time frame: 7.5 days

Sponsors and collaborators

Lead sponsor

Logical Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2008
Registry last updated
Oct 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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