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

Logical Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Naprosyn®; Drug: LT-NS001

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063920

LT-NS001-003

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 534 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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534 participants in 2 patient groups

LT-NS001

Experimental group

Description:

LT-NS001 1200 mg b.i.d. p.o. for 12 weeks

Treatment:

Drug: LT-NS001

Naprosyn®

Active Comparator group

Description:

Naprosyn® 500 mg b.i.d for 12 weeks

Treatment:

Drug: Naprosyn®