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

This study has been completed.

First Received on September 8, 2008. Last Updated on October 4, 2010 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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
Experimental: A	Drug: LT-NS001 1200 mg b.i.d. p.o. for 7.5 days
Active Comparator: B	Drug: Naprosyn® 500 mg b.i.d. p.o. for 7.5 days Other Name: Naprosyn®

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 by Logical Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldstein JL, Jungwirthová A, David J, Spindel E, Bouchner L, Pešek F, Searle S, Skopek J, Grim J, Ul? 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. Epub 2010 Aug 23.

Responsible Party:	K. Lea Sewell, M.D., Logical Therapeutics
ClinicalTrials.gov Identifier:	NCT00750243 History of Changes
Other Study ID Numbers:	LT-NS001-002
Study First Received:	September 8, 2008
Last Updated:	October 4, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012