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

20. januar 2011 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

534

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LT-NS001
LT-NS001 1200 mg b.i.d. p.o. for 12 weeks
Medicin: LT-NS001
1200 mg b.i.d. p.o. for 12 weeks
Aktiv komparator: Naprosyn®
Naprosyn® 500 mg b.i.d for 12 weeks
Medicin: Naprosyn®
500 mg b.i.d. p.o. for 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Gastric Ulcer by Endoscopy
Tidsramme: Baseline, Day 29, Day 57 and Day 85
Baseline, Day 29, Day 57 and Day 85

Sekundære resultatmål

Resultatmål
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Tidsramme: 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
Tidsramme: Two separate days after Day 14, at least two weeks apart
Two separate days after Day 14, at least two weeks apart

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Logical Therapeutics

Samarbejdspartnere

PRA Health Sciences

Efterforskere

  • Ledende efterforsker: Jay L Goldstein, MD, University of Illinois at Chicago, Department of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

29. januar 2010

Først indsendt, der opfyldte QC-kriterier

4. februar 2010

Først opslået (Skøn)

5. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. januar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2011

Sidst verificeret

1. januar 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LT-NS001-003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slidgigt

Kliniske forsøg med LT-NS001

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Canada

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner