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

Information source: Logical Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: LT-NS001 (Drug); Naprosyn® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Logical Therapeutics

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary outcome: Assessment of GI mucosal injury by endoscopy

Secondary outcome: Comparison of naproxen PK at steady state

Eligibility

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Illinois at Chicago, Chicago, Illinois 60612, United States
Additional Information

Starting date: September 2008
Last updated: October 4, 2010

Page last updated: August 23, 2015

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