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A Safety and Efficacy Study of Daikenchuto (TU-100) to Treat Crohn's Disease

18. maj 2015 opdateret af: Tsumura USA

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of Daikenchuto (TU-100) in Subjects With Moderate Crohn's Disease

The purpose of this study is to determine whether Daikenchuto(TU-100)is effective in the treatment of Crohn's disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Crohn's disease, a chronic condition resulting in inflammation of the gastrointestinal tract (GI), causes a person to experience persistent symptoms of inflammatory bowel disease, including abdominal pain, nausea, vomiting, rectal bleeding, diarrhea, and constipation, with infrequent bowel movements that are at times accompanied by a sensation of incomplete emptying after having a bowel movement. Tsumura's TU-100 is a modern herbal product that has been approved as a prescription drug in Japan. Several lines of evidence indicate that TU-100 attenuates intestinal inflammation in Crohn's disease by increasing intestinal blood flow and stimulating a protective lining of intestinal mucus which produces an anti-inflammatory effect. TU-100 may attenuate pathological changes in the intestine and reduce symptoms in patients with Crohn's disease.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

79

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Preferred Research Partners Inc
    • California
      • Corona, California, Forenede Stater, 92880
        • TRIMED Clinical Trials
      • San Carlos, California, Forenede Stater, 94070
        • Digestive Care Associates, LLC
      • San Francisco, California, Forenede Stater, 94115
        • University of California at San Francisco
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80215
        • Rocky Mountain Gastroenterology Associates
    • Florida
      • Clearwater, Florida, Forenede Stater, 22765
        • Clinical Research of West Florida, Inc
      • Naples, Florida, Forenede Stater, 34102
        • Gastroenterology Group Of Naples
      • Winter Park, Florida, Forenede Stater, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30542-5020
        • Atlanta Gastroenterology Associates, LLC
      • Macon, Georgia, Forenede Stater, 31210
        • Gastroenterology Associates of Central Georgia
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Hospital Medical Center
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • University of Louisville School of Medicine
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Metropolitan Gastroenterology Group. PC
      • Towson, Maryland, Forenede Stater, 21204
        • Endoscopic Microsurgery Associates PA
    • Massachusetts
      • Quincy, Massachusetts, Forenede Stater, 02169
        • MedRACS
    • Michigan
      • Chesterfield, Michigan, Forenede Stater, 48047
        • Clinical Research Institute of Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Center for Digestive Health
    • Mississippi
      • Ocean Springs, Mississippi, Forenede Stater, 39564
        • Digestive Health Center
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63128
        • St. Louis Center for Clinical Research
    • New York
      • Great Neck, New York, Forenede Stater, 11021
        • Long Island Clinical Research Associates, LLP
      • Hollis, New York, Forenede Stater, 11423
        • NY Scientific CORP
    • North Carolina
      • Salisbury, North Carolina, Forenede Stater, 28144
        • PMG Research of Salisbury
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Consultants for Clinical Research
      • Cincinnati, Ohio, Forenede Stater, 45014
        • Ohio Gastroenterology and Liver
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Advanced Research Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • provide written informed consent
  • ability to orally ingest study medication
  • male or female between 18 to 75 inclusive
  • diagnosed with Crohn's disease for at least 3 months
  • CDAI score of 220-300 at screening
  • sexually active participants of childbearing potential must agree to birth control
  • no clinically significant conditions which the doctor would feel exclusionary
  • stable medication (including probiotics)

Exclusion Criteria:

  • history of any bowel condition that may interfere with the evaluation of the study drug
  • positive stool cultures
  • currently pregnant or lactating
  • receiving total parenteral nutrition
  • history of alcohol or drug abuse within one year
  • history of malignancy within 5 years
  • current use of anticholinergic agents, antidepressants during the study, warfarin, prokinetics, antipsychotic agents or narcotic analgesics
  • treatment with Anti-TNF agents 12 weeks before screening
  • treatment with corticosteroids four weeks prior to screening
  • treatment with cyclosporine or tacrolimus eight weeks prior to screening
  • presence of a poorly controlled medical condition
  • history of allergic reaction to ginseng, ginger or sichuan pepper
  • any use of supplemental ginger, ginseng and Sichuan powder 2 weeks prior to and through course of the trial
  • current use of any of the following herbal medications: Boswellia, Cat's claw (Uncaria tomentosa), Cayenne pepper, Echinacea, Horsetail (Equisetum), Hops, Lady's mantle (Alchemilla), Marshmallow root (Althaea), Slippery elm (Ulmus rubra) Turmeric and White Willow (Salix alba)
  • history of celiac disease
  • current diagnosis of lactose intolerance
  • history of any other investigational medication within 30 days of enrolling in study
  • unsuitability as determined by the study doctor

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
Medicin: TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Andre navne:
  • Daikenchuto
Placebo komparator: Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
Medicin: Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Andre navne:
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Clinical response as measured by a reduction in the CDAI total score
Tidsramme: over eight weeks
over eight weeks

Sekundære resultatmål

Resultatmål
Tidsramme
CDAI reduction by number of points and difference from baseline
Tidsramme: over eight weeks
over eight weeks
proportion of subjects showing a clinical remission by measure of CDAI score
Tidsramme: over eight weeks
over eight weeks
The change in total CDAI score
Tidsramme: every four weeks over eight weeks
every four weeks over eight weeks
The change in IBDQ total score and category sub-scores
Tidsramme: every four weeks over eight weeks
every four weeks over eight weeks
The change in CRP level
Tidsramme: every four weeks over eight weeks
every four weeks over eight weeks
The change in fecal calprotectin levels
Tidsramme: over eight weeks
over eight weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Tsumura USA

Samarbejdspartnere

Syneos Health

Efterforskere

  • Studieleder: Shunji Mochida, Ph.D., Tsumura USA

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. september 2011

Primær færdiggørelse (Faktiske)

1. september 2013

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

5. juli 2011

Først indsendt, der opfyldte QC-kriterier

5. juli 2011

Først opslået (Skøn)

7. juli 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TU100P2T2

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 Crohns sygdom

Kliniske forsøg med TU-100

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner