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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063920
• Other study ID #: LT-NS001-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 29, 2010
• Last updated: January 20, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Logical Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Stomach Ulcer

Intervention

Drug:
• LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
• Naprosyn®
500 mg b.i.d. p.o. for 12 weeks

Locations

Country	Name	City	State
United States	Radiant Research-Akron	Akron	Ohio
United States	Orange County Clinical Trials	Anaheim	California
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland
United States	Delta Research Partners LLC	Bastrop	Louisiana
United States	Montana Health Research Institute Inc.	Billings	Montana
United States	Greystone Medical Research, LLC	Birmingham	Alabama
United States	Theresa Sligh, MD	Burbank	California
United States	Radiant Research	Chandler	Arizona
United States	Carolina Digestive Health Associates PA	Charlotte	North Carolina
United States	Metropolitan Gastroenterolgy Group PC	Chevy Chase	Maryland
United States	Thomas Schnitzer, MD	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Clifton-Wallington Medical Group	Clifton	New Jersey
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Corsicana Medical Research PLLC	Corsicana	Texas
United States	Galenos Research	Dallas	Texas
United States	Physicians Research Options LLC	Draper	Utah
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MediSphere Medical Research Center LLC	Evansville	Indiana
United States	Welborn Clinic	Evansville	Indiana
United States	Arthritis and Osteoporosis Cener of Maryland	Frederick	Maryland
United States	Eastern Clinical Research Unit	Hialeah	Florida
United States	Peters Medical Research LLC	High Point	North Carolina
United States	MidAtlantic Medical Research Centers/Bean Medical Center	Hollywood	Maryland
United States	Clinical Trial Network	Houston	Texas
United States	Houston Endoscopy and Research Center	Houston	Texas
United States	Houston Medical Research Associates	Houston	Texas
United States	Clinical Research Associates	Huntsville	Alabama
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Drug Study Institute	Jupiter	Florida
United States	Dynamic Clinical Research	Kansas City	Missouri
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Affiliated Clinical Research Inc.	Las Vegas	Nevada
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Torrance Clinical Research	Lomeita	California
United States	West Gastroenterology Associates	Los Angeles	California
United States	Venture Resource Group Inc.	Mission	Kansas
United States	Facey Medical Center	Mission HIlls	California
United States	Research Across America	New York	New York
United States	Clinical Research Associates LLC	Oklahoma City	Oklahoma
United States	Health Research of Oklahoma	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Pinnacle Medical Research	Overland Park	Kansas
United States	Desert Medical Group	Palm Springs	California
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	Keith Klatt, MD	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Allergy Asthma Immunology of Rochester Research Center	Rochester	New York
United States	Quality Research Inc.	San Antonio	Texas
United States	Cynthia Schaeffer, MD	San Diego	California
United States	Medical Affiliated Research Center Inc.	San Diego	California
United States	Medical Associates Research Group	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Sundance Clinical Research	St. Louis	Missouri
United States	Dedicated Clinical Research Inc.	Surprise	Arizona
United States	Adobe Gastroenterology Research, LLC	Tucson	Arizona
United States	Genova Clinical Research Inc.	Tucson	Arizona
United States	Radiant Research Inc.	Tucson	Arizona
United States	Arthritis and Osteoporosis Clinic Research Center of Central Texas	Waco	Texas
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Gold Coast Research LLC	Weston	Florida
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Logical Therapeutics	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Ulcer by Endoscopy		Baseline, Day 29, Day 57 and Day 85	Yes
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score		Screening, Baseline, Days 15, 29, 57 and 85	No
Secondary	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	No