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Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

23. juni 2005 opdateret af: Incara Pharmaceuticals

A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis

This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a double-blind, placebo-controlled, research study to evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis. Patients will be randomized (assigned by chance like the toss of a coin) to receive 75 mg OP2000, 125 mg OP2000, or placebo once daily for 6 weeks. Study drug will be administered by subcutaneous (under the skin) injection and patients will be taught how to self-administer these injections. Following an initial Screening Visit, eligible patients will return to the clinic for initiation of study treatment and then again for follow-up visits after 1, 2, 4 and 6 weeks of treatment. A follow-up telephone call will be scheduled 2 months (and possibly also 4 and 6 months) after completing study treatment. Study procedures will include a flexible sigmoidoscopy at the Screening Visit and at the Week 6 visit.

Undersøgelsestype

Interventionel

Tilmelding

270

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
    • California
      • Anaheim, California, Forenede Stater, 92801
        • AGMG Clinical Research
      • Orange, California, Forenede Stater, 92868
        • Community Clinical Trials
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80215
        • Rocky Mountain Gastroenterology Associates
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Clinical Research
    • Florida
      • Gainesville, Florida, Forenede Stater, 32608
        • University of Florida Gainesville/Gainesville VAMC
      • Jacksonville, Florida, Forenede Stater, 32223
        • Borland-Groover Clinic
      • Miami, Florida, Forenede Stater, 33173
        • Miami Research Associates
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami, Division of Clinical Pharmacology
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Atlanta Gastroenterology Associates, Llc
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • Univ. of Kentucky Medical Center
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Metropolitan Gastroenterology Group
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Health System
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55114
        • Minnesota Clinical Research Center
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Washington Univ. School of Medicine
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68503
        • Gastroenterology Specialties, PC
    • New York
      • Great Neck, New York, Forenede Stater, 11021
        • Long Island Clinical Research Associates
      • New York, New York, Forenede Stater, 10028
        • Daniel H. Present, MD
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • Univ. of North Carolina Hospital
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Health Center
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Wake Research Associates, LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma Foundation for Digestive Research
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Gastroenterology United of Tulsa
    • Oregon
      • Portland, Oregon, Forenede Stater, 97225
        • West Hills Gastroenterology
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the Univ. of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Memphis Gastroenterology Group, PC
      • Nashville, Tennessee, Forenede Stater, 37211
        • Nashville Clinical Research
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76102
        • GANT Research, PA
      • San Antonio, Texas, Forenede Stater, 78229
        • Gastroenterology Clinic of San Antonio
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • Univ. of Virginia Health System
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53207
        • Wisconsin Center for Advanced Research, 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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.
  • Treatment with aminosalicylates at least 28 days, if tolerated.
  • Duration of current flare-up at least 7 days.
  • Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.

Exclusion Criteria:

  • Disease limited to the rectum.
  • Toxic megacolon.
  • The use of anticoagulant drugs.
  • A history of any bleeding disorder.
  • A history of heparin-induced thrombocytopenia.
  • Evidence of liver or kidney impairment.
  • Women who are pregnant or breast feeding.

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

Samarbejdspartnere og efterforskere

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

Sponsor

Incara Pharmaceuticals

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. januar 2001

Studieafslutning

1. september 2002

Datoer for studieregistrering

Først indsendt

16. april 2002

Først indsendt, der opfyldte QC-kriterier

16. april 2002

Først opslået (Skøn)

17. april 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. oktober 2002

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OP201

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 .

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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