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).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates|
- Gastric Ulcer by Endoscopy [ Time Frame: Baseline, Day 29, Day 57 and Day 85 ] [ Designated as safety issue: Yes ]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score [ Time Frame: Screening, Baseline, Days 15, 29, 57 and 85 ] [ Designated as safety issue: No ]
- Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen [ Time Frame: Two separate days after Day 14, at least two weeks apart ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
1200 mg b.i.d. p.o. for 12 weeks
Active Comparator: Naprosyn®
Naprosyn® 500 mg b.i.d for 12 weeks
500 mg b.i.d. p.o. for 12 weeks
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.
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|Principal Investigator:||Jay L Goldstein, MD||University of Illinois at Chicago, Department of Medicine|