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

18. mai 2015 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

79

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TU-100
15g TU-100 (oral, daily) for 8 consecutive weeks (administered as 5g three times daily)
Legemiddel: TU-100
15g daily, orally as 5g three times daily for 8 consecutive weeks
Andre navn:
  • Daikenchuto
Placebo komparator: Matching placebo
Matching placebo given 5g three times daily orally for 8 consecutive weeks
Legemiddel: Matching Placebo
15g as 5g three times daily, orally for 8 consecutive weeks
Andre navn:
  • Placebo

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tsumura USA

Samarbeidspartnere

Syneos Health

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. september 2013

Datoer for studieregistrering

Først innsendt

5. juli 2011

Først innsendt som oppfylte QC-kriteriene

5. juli 2011

Først lagt ut (Anslag)

7. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. juni 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mai 2015

Sist bekreftet

1. mai 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TU100P2T2

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