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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Logical Therapeutics
• Collaborator: PRA Health Sciences
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• Osteoarthritis of knee

• Appropriate candidate for chronic NSAID therapy due to moderate or severe pain on most days in the 28 days before screening for study.

Exclusion Criteria:

• Pregnant/Nursing women

• History of GI bleeding, perforation or obstruction

• A documented symptomatic GI ulcer during past 5 years

• Presence of GI ulcer or more than 2 erosions on screening endoscopy

• Allergy to naproxen (or naproxen intolerance), acetylsalicylic acid, or other NSAID drug