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

This study has been completed.
Sponsor:
Information provided by:
Logical Therapeutics
ClinicalTrials.gov Identifier:
NCT00750243
First received: September 8, 2008
Last updated: October 4, 2010
Last verified: October 2010
History of Changes
  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 1

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
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):

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 June 17, 2013