Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
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).
This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn®
 for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for
 ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at
 week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary
 objectives include assessment of pain in the affected knee by WOMAC questionnaire to
 demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information
 about gastrointestinal pain and tolerability will be collected.

 The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week
 treatment period and a 4 week post treatment monitoring period.
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