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

This study has been completed.

First Received: September 8, 2008 Last Updated: September 14, 2009 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

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 ]

Enrollment:	120
Study Start Date:	September 2008
Study Completion Date:	April 2009
Primary Completion Date:	February 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

Locations

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

Sponsors and Collaborators

Logical Therapeutics

More Information

No publications provided

Responsible Party:	Logical Therapeutics ( K. Lea Sewell, M.D. )
Study ID Numbers:	LT-NS001-002
Study First Received:	September 8, 2008
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00750243 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
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 February 08, 2010