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Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®

NCT01063920 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2011-01-24

No results posted yet for this study

Summary

LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA).

Conditions

Interventions

DRUG

LT-NS001

1200 mg b.i.d. p.o. for 12 weeks

DRUG

Naprosyn®

500 mg b.i.d. p.o. for 12 weeks

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Logical Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jay L Goldstein, MD · University of Illinois at Chicago, Department of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01063920 on ClinicalTrials.gov