Comparator Study of LT-NS001 in Healthy Subjects With Endoscopic Evaluation
Information source: Logical Therapeutics
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: LT-NS001 (Drug); Naprosyn® (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Logical Therapeutics Overall contact:
Deborah Bua, Phone: 781-290-0900, Ext: 468, Email: buadj@logicaltherapeutics.com
Summary
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.
Clinical Details
Official title: A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Primary outcome: Assessment of GI mucosal injury by endoscopy
Secondary outcome: Comparison of naproxen PK at steady state
Eligibility
Minimum age: 45 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Deborah Bua, Phone: 781-290-0900, Ext: 468, Email: buadj@logicaltherapeutics.com
University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting
Additional Information
Starting date: September 2008
Ending date: May 2009
Last updated: September 8, 2008
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