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

January 20, 2011 updated by: Logical Therapeutics

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
534

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Greystone Medical Research, LLC
      • Huntsville, Alabama, United States, 35801
        • Clinical Research Associates
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research
      • Surprise, Arizona, United States, 85340
        • Dedicated Clinical Research Inc.
      • Tucson, Arizona, United States, 85710
        • Radiant Research Inc.
      • Tucson, Arizona, United States, 85712
        • Adobe Gastroenterology Research, LLC
      • Tucson, Arizona, United States, 85741
        • Genova Clinical Research Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92801
        • Orange County Clinical Trials
      • Burbank, California, United States, 91505
        • Theresa Sligh, MD
      • Lomeita, California, United States, 90274
        • Torrance Clinical Research
      • Los Angeles, California, United States, 90045
        • West Gastroenterology Associates
      • Mission HIlls, California, United States, 91345
        • Facey Medical Center
      • Palm Springs, California, United States, 92262
        • Desert Medical Group
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 35801
        • Medical Affiliated Research Center Inc.
      • San Diego, California, United States, 92114
        • Cynthia Schaeffer, MD
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Lynn Institute of the Rockies
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Center for Clinical Research
    • Florida
      • Hialeah, Florida, United States, 33013
        • Eastern Clinical Research Unit
      • Inverness, Florida, United States, 33452
        • Nature Coast Clinical Research
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research Inc.
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research LLC
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33317
        • Gold Coast Research LLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Thomas Schnitzer, MD
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Welborn Clinic
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center LLC
    • Kansas
      • Mission, Kansas, United States, 66202
        • Venture Resource Group Inc.
      • Overland Park, Kansas, United States, 66215
        • Pinnacle Medical Research
    • Louisiana
      • Bastrop, Louisiana, United States, 71201
        • Delta Research Partners LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterolgy Group Pc
      • Frederick, Maryland, United States, 21702
        • Arthritis and Osteoporosis Cener of Maryland
      • Hollywood, Maryland, United States, 20636
        • MidAtlantic Medical Research Centers/Bean Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Dynamic Clinical Research
      • St. Louis, Missouri, United States, 63141
        • Sundance Clinical Research
    • Montana
      • Billings, Montana, United States, 59102
        • Montana Health Research Institute Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
      • Las Vegas, Nevada, United States, 89144
        • Affiliated Clinical Research Inc.
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Clifton-Wallington Medical Group
    • New York
      • New York, New York, United States, 10022
        • Research Across America
      • Rochester, New York, United States, 14618
        • Allergy Asthma Immunology of Rochester Research Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28075
        • Carolina Digestive Health Associates PA
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research LLC
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research-Akron
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
      • Oklahoma City, Oklahoma, United States, 73116
        • Clinical Research Associates LLC
    • Oregon
      • Portland, Oregon, United States, 97739
        • Keith Klatt, MD
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Texas
      • Corsicana, Texas, United States, 75110
        • Corsicana Medical Research PLLC
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Houston, Texas, United States, 77079
        • Houston Endoscopy and Research Center
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77090
        • Houston Medical Research Associates
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
      • Waco, Texas, United States, 76708
        • Arthritis and Osteoporosis Clinic Research Center of Central Texas
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians Research Options LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LT-NS001
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Drug: LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
Active Comparator: Naprosyn®
Naprosyn® 500 mg b.i.d for 12 weeks
Drug: Naprosyn®
500 mg b.i.d. p.o. for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Gastric Ulcer by Endoscopy
Time Frame: Baseline, Day 29, Day 57 and Day 85
Baseline, Day 29, Day 57 and Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time Frame: Screening, Baseline, Days 15, 29, 57 and 85
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
Time Frame: Two separate days after Day 14, at least two weeks apart
Two separate days after Day 14, at least two weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Logical Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PRA Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jay L Goldstein, MD, University of Illinois at Chicago, Department of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LT-NS001-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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