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Trial of IW-9179 in Patients With Diabetic Gastroparesis (DGP)

1. december 2016 opdateret af: Ironwood Pharmaceuticals, Inc.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis

The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

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
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35203
        • Ironwood Investigational Site
      • Dothan, Alabama, Forenede Stater, 36305
        • Ironwood Investigational Site
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85710
        • Ironwood Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Ironwood Investigational Site
    • California
      • Chula Vista, California, Forenede Stater, 91910
        • Ironwood Investigational Site
      • Los Angeles, California, Forenede Stater, 90036
        • Ironwood Investigational Site
      • Ventura, California, Forenede Stater, 93003
        • Ironwood Investigational Site
    • Florida
      • Miami, Florida, Forenede Stater, 33122
        • Ironwood Investigational Site
      • Tampa, Florida, Forenede Stater, 33607
        • Ironwood Investigational Site
    • Illinois
      • Urbana, Illinois, Forenede Stater, 61801
        • Ironwood Investigational Site
    • Louisiana
      • Bastrop, Louisiana, Forenede Stater, 71220
        • Ironwood Investigational Site
    • Michigan
      • Chesterfield, Michigan, Forenede Stater, 48047
        • Ironwood Investigational Site
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Ironwood Investigational Site
    • New York
      • Great Neck, New York, Forenede Stater, 11023
        • Ironwood Investigational Site
      • New York, New York, Forenede Stater, 10018
        • Ironwood Investigational Site
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Ironwood Investigational Site
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27410
        • Ironwood Investigational Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Ironwood Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37421
        • Ironwood Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77015
        • Ironwood Investigational Site
      • Webster, Texas, Forenede Stater, 77598
        • Ironwood Investigational Site
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Ironwood Investigational Site

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is a male or non-pregnant, non-breastfeeding female, and is age 18 years or older at the time of the Screening Visit.
  • Patient has a confirmed diagnosis of type 1 or type 2 diabetes mellitus.
  • Patient has a diagnosis of DGP with no history or evidence of mechanical obstruction, symptoms for at least 3 consecutive months preceding the Screening Visit, and delayed gastric emptying of solids documented within 2 years of the Screening Visit.
  • Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient's gastroduodenal symptoms.
  • Patient is compliant with eDiary completion.
  • Patient agrees to refrain from making any new, major lifestyle changes.
  • Patient is fluent and literate in English.

Exclusion Criteria:

  • Patient has a history or current symptoms of any organic or structural disease that, in the opinion of the investigator, can cause abdominal pain or discomfort and may confound the assessment of DGP symptoms.
  • Patients with rumination syndrome, cyclic vomiting syndrome, anorexia nervosa, or bulimia.
  • Patient is currently using a gastric electric stimulator or has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
  • Patient has been hospitalized within the 2 months prior to the Screening Visit for uncontrolled diabetes mellitus, DGP, or associated malnutrition.
  • Patient reports significant diarrhea during the four weeks prior to the Screening Visit, or more than 2 days during either week of the Pretreatment Period.
  • Patient has had surgery of the GI tract any time before the Screening Visit, an appendectomy or cholecystectomy during the 3 months before the Screening Visit, non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months, or other major non-GI surgery during the 30 days before the Screening Visit.
  • Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable).

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo BID
Placebo once in the morning and once in the evening.
Medicin: Matchende placebo
Eksperimentel: IW-9179 QD AM + Placebo QD PM
IW-9179 once in the morning and placebo once in the evening.
Medicin: Matchende placebo
Medicin: IW-9179
Eksperimentel: Placebo QD AM + IW-9179 QD PM
Placebo once in the morning and IW-9179 once in the evening.
Medicin: Matchende placebo
Medicin: IW-9179
Eksperimentel: IW-9179 BID
IW-9179 once in the morning and once in the evening
Medicin: IW-9179

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms
Tidsramme: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period

Samarbejdspartnere og efterforskere

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

Sponsor

Ironwood Pharmaceuticals, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. oktober 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

10. november 2014

Først indsendt, der opfyldte QC-kriterier

10. november 2014

Først opslået (Skøn)

13. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. december 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICP-112-202

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 Diabetisk gastroparese

Kliniske forsøg med Matchende placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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