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

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: LT-NS001; Drug: Naprosyn®

• Registration Number: NCT01063920
• Lead Sponsor: Logical Therapeutics

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2010-01-29
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LT-NS001	LT-NS001	LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Naprosyn®	Naprosyn®	Naprosyn® 500 mg b.i.d for 12 weeks

Primary Outcome Measures

Name	Time	Method
Gastric Ulcer by Endoscopy	Baseline, Day 29, Day 57 and Day 85

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score	Screening, Baseline, Days 15, 29, 57 and 85
Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen	Two separate days after Day 14, at least two weeks apart

Trial Locations

Locations (64)

Greystone Medical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Radiant Research; 🇺🇸 Pinellas Park, Florida, 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

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