Clinical trial NCT01063920: Rates of Gastric Ulcer by Endoscopy in Knee Osteoarthritis Patients Receiving LT-NS001 Versus Naprosyn®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Keywords: LT-NS001
Gastric Ulcers
NSAID
Osteoarthritis
Naproxen
Lead sponsor: Logical Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2010-02-05
Enrollment: 534
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric Ulcer by Endoscopy
timeFrame: Baseline, Day 29, Day 57 and Day 85
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: Screening, Baseline, Days 15, 29, 57 and 85
measure: Population pharmacokinetic analysis will assess the influence of covariates on the absorption/metabolism of LT-NS001 to naproxen
timeFrame: Two separate days after Day 14, at least two weeks apart
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Surprise
country: United States
facility: Dedicated Clinical Research Inc.
state: Arizona
city: Tucson
country: United States
facility: Radiant Research Inc.
state: Arizona
city: Tucson
country: United States
facility: Adobe Gastroenterology Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research Inc.
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Burbank
country: United States
facility: Theresa Sligh, MD
state: California
city: Lomeita
country: United States
facility: Torrance Clinical Research
state: California
city: Los Angeles
country: United States
facility: West Gastroenterology Associates
state: California
city: Mission HIlls
country: United States
facility: Facey Medical Center
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group
state: California
city: San Diego
country: United States
facility: Medical Affiliated Research Center Inc.
state: California
city: San Diego
country: United States
facility: Cynthia Schaeffer, MD
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Hialeah
country: United States
facility: Eastern Clinical Research Unit
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research LLC
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Gold Coast Research LLC
state: Florida
city: Chicago
country: United States
facility: Thomas Schnitzer, MD
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center LLC
state: Indiana
city: Mission
country: United States
facility: Venture Resource Group Inc.
state: Kansas
city: Overland Park
country: United States
facility: Pinnacle Medical Research
state: Kansas
city: Bastrop
country: United States
facility: Delta Research Partners LLC
state: Louisiana
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterolgy Group PC
state: Maryland
city: Frederick
country: United States
facility: Arthritis and Osteoporosis Cener of Maryland
state: Maryland
city: Hollywood
country: United States
facility: MidAtlantic Medical Research Centers/Bean Medical Center
state: Maryland
city: Kansas City
country: United States
facility: Dynamic Clinical Research
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute Inc.
state: Montana
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Las Vegas
country: United States
facility: Affiliated Clinical Research Inc.
state: Nevada
city: Clifton
country: United States
facility: Clifton-Wallington Medical Group
state: New Jersey
city: New York
country: United States
facility: Research Across America
state: New York
city: Rochester
country: United States
facility: Allergy Asthma Immunology of Rochester Research Center
state: New York
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates PA
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Akron
country: United States
facility: Radiant Research-Akron
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Clinical Research Associates LLC
state: Oklahoma
city: Portland
country: United States
facility: Keith Klatt, MD
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Corsicana
country: United States
facility: Corsicana Medical Research PLLC
state: Texas
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Houston Endoscopy and Research Center
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: Waco
country: United States
facility: Arthritis and Osteoporosis Clinic Research Center of Central Texas
state: Texas
city: Draper
country: United States
facility: Physicians Research Options LLC
state: Utah
Study officials:
affiliation: University of Illinois at Chicago, Department of Medicine
name: Jay L Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: