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CompletedNCT00750243Updated Oct 6, 2010

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

A Phase 1 interventional study of LT-NS001 and Naprosyn® in Healthy, sponsored by Logical Therapeutics. Completed at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-06.

Sponsored by Logical Therapeutics · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Logical Therapeutics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant/Nursing women
  • History of documented gastroduodenal ulcer
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    A

    Drug: LT-NS001

  • Active comparator
    B

    Drug: Naprosyn®

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

06

What researchers measure

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

07

Study locations

1 site
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
08

References and documents

Publications

  • 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. PubMed 20804454 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00750243
Lead sponsor
Logical Therapeutics
First posted
Sep 10, 2008
Start date
Sep 2008
Primary completion
Feb 2009
Completion
Apr 2009
Last update
Oct 6, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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