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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750243
First Posted: September 10, 2008
Last Update Posted: October 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Logical Therapeutics
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Logical Therapeutics:

Primary Outcome Measures:
  • Assessment of GI mucosal injury by endoscopy [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Comparison of naproxen PK at steady state [ Time Frame: 7.5 days ]

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750243


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Logical Therapeutics
  More Information

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
First Submitted: September 8, 2008
First Posted: September 10, 2008
Last Update Posted: October 6, 2010
Last Verified: October 2010

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
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action