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

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

This study is currently recruiting participants.
Verified by Logical Therapeutics, September 2008

Sponsored by:	Logical Therapeutics
Information provided by:	Logical Therapeutics
ClinicalTrials.gov Identifier:	NCT00750243

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: LT-NS001 Drug: Naprosyn®	Phase I Phase II

MedlinePlus related topics:

Endoscopy

ChemIDplus related topics:

Naproxen sodium Naproxen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Logical Therapeutics:

Primary Outcome Measures:

Assessment of GI mucosal injury by endoscopy [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparison of naproxen PK at steady state [ Time Frame: 7.5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: LT-NS001 1200 mg b.i.d. p.o. for 7.5 days
B: Active Comparator	Drug: Naprosyn® 500 mg b.i.d. p.o. for 7.5 days

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750243

Contacts


Contact: Deborah Bua	781-290-0900 ext 468	buadj@logicaltherapeutics.com

Locations


United States, Illinois
	University of Illinois at Chicago	Recruiting
	Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Logical Therapeutics

More Information

Responsible Party:	Logical Therapeutics ( K. Lea Sewell, M.D. )
Study ID Numbers:	LT-NS001-002
First Received:	September 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00750243
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Naproxen

Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Gout Suppressants

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 06, 2008