drugset / Trial / NCT01063920

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

NCT01063920

Phase 2/3 Completed 534 enrolled Logical Therapeutics PRA Health Sciences · collab
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2010-02
Primary completion
2010-11
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NAPROXEN ETEMESIL Small molecule 1200 mg Oral
Comparator Naproxen Small molecule 500 mg Oral

Indications