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

Completed · Phase 2/Phase 3

Conditions studied: Osteoarthritis

In brief

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).

Key facts

Study ID

NCT01063920

Run by

Logical Therapeutics

People needed

534

Starts

2010-02-01

Expected to finish

2010-11-01

Last updated by the study team

2011-01-24

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Radiant Research — Chandler, Arizona, United States
• Dedicated Clinical Research Inc. — Surprise, Arizona, United States
• Radiant Research Inc. — Tucson, Arizona, United States
• Adobe Gastroenterology Research, LLC — Tucson, Arizona, United States
• Genova Clinical Research Inc. — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Orange County Clinical Trials — Anaheim, California, United States
• Theresa Sligh, MD — Burbank, California, United States
• Torrance Clinical Research — Lomeita, California, United States
• West Gastroenterology Associates — Los Angeles, California, United States
• Facey Medical Center — Mission Hills, California, United States
• Desert Medical Group — Palm Springs, California, United States
• Medical Affiliated Research Center Inc. — San Diego, California, United States
• Cynthia Schaeffer, MD — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Lynn Institute of the Rockies — Colorado Springs, Colorado, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• Eastern Clinical Research Unit — Hialeah, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• University Clinical Research Inc. — Pembroke Pines, Florida, United States
• Radiant Research — Pinellas Park, Florida, United States
• Accord Clinical Research LLC — Port Orange, Florida, United States
• Greystone Medical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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