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Rifaximin 3 Times/Day (TID) for Non-Constipation Irritable Bowel Syndrome (IBS) (TARGET 1)

26. november 2019 opdateret af: Bausch Health Americas, Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin 550 mg TID in the Treatment of Subjects With Non-Constipation Irritable Bowel Syndrome

To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

623

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2E2
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton, Ontario, Canada, L9N 4A6
      • London, Ontario, Canada, N6A 5R8
      • London, Ontario, Canada, N6A 5R9
      • Newmarket, Ontario, Canada, L3Y 5G8
      • Niagara Falls, Ontario, Canada, L2G 1J4
      • Sarnia, Ontario, Canada, N7T 4X3
  • Forenede Stater
    • Alabama
      • Hueytown, Alabama, Forenede Stater, 35023
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85050
      • Sierra Vista, Arizona, Forenede Stater, 85635
      • Tucson, Arizona, Forenede Stater, 85741
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
      • Little Rock, Arkansas, Forenede Stater, 72204
      • Sherwood, Arkansas, Forenede Stater, 72120
    • California
      • Anaheim, California, Forenede Stater, 92801
      • Lancaster, California, Forenede Stater, 93534
      • Los Angeles, California, Forenede Stater, 90045
      • Murrieta, California, Forenede Stater, 92562
      • San Diego, California, Forenede Stater, 92108
    • Colorado
      • Lakewood, Colorado, Forenede Stater, 80215
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
      • Torrington, Connecticut, Forenede Stater, 06790
    • Florida
      • Altamonte Springs, Florida, Forenede Stater, 32701
      • Boynton Beach, Florida, Forenede Stater, 33426
      • Gainesville, Florida, Forenede Stater, 32607
      • Hollywood, Florida, Forenede Stater, 33021
      • Jupiter, Florida, Forenede Stater, 33458
      • Lauderdale Lakes, Florida, Forenede Stater, 33319
      • Maitland, Florida, Forenede Stater, 32751
      • Naples, Florida, Forenede Stater, 34102
      • New Port Richey, Florida, Forenede Stater, 34652
      • Orlando, Florida, Forenede Stater, 32806
      • West Palm Beach, Florida, Forenede Stater, 33409
      • Winter Garden, Florida, Forenede Stater, 34787
      • Winter Park, Florida, Forenede Stater, 32708
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71103
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
      • Hagerstown, Maryland, Forenede Stater, 21742
      • Silver Spring, Maryland, Forenede Stater, 20901
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48235
      • Kalamazoo, Michigan, Forenede Stater, 49008
      • Paw Paw, Michigan, Forenede Stater, 49079
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39202
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
    • New Jersey
      • Elizabeth, New Jersey, Forenede Stater, 07202
      • Lumberton, New Jersey, Forenede Stater, 08048
    • New York
      • Bayside, New York, Forenede Stater, 11358
      • Brooklyn, New York, Forenede Stater, 11214
      • New York, New York, Forenede Stater, 10021
      • Troy, New York, Forenede Stater, 12180
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
      • Charlotte, North Carolina, Forenede Stater, 28207
      • Durham, North Carolina, Forenede Stater, 27713
      • Fayetteville, North Carolina, Forenede Stater, 28304
      • Greensboro, North Carolina, Forenede Stater, 27408
      • High Point, North Carolina, Forenede Stater, 27262
      • Mooresville, North Carolina, Forenede Stater, 28117
      • Raleigh, North Carolina, Forenede Stater, 27609
      • Salisbury, North Carolina, Forenede Stater, 28144
      • Wilmington, North Carolina, Forenede Stater, 28401
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
      • Cleveland, Ohio, Forenede Stater, 44122
      • Columbus, Ohio, Forenede Stater, 43215
      • Dayton, Ohio, Forenede Stater, 45440
      • Zanesville, Ohio, Forenede Stater, 43701
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74104
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
      • Portland, Oregon, Forenede Stater, 97225
    • Pennsylvania
      • Lancaster, Pennsylvania, Forenede Stater, 17601
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
      • Jackson, Tennessee, Forenede Stater, 38301
      • Johnson City, Tennessee, Forenede Stater, 37604
      • Nashville, Tennessee, Forenede Stater, 37203
    • Texas
      • Austin, Texas, Forenede Stater, 78705
      • Fort Worth, Texas, Forenede Stater, 76104
      • Houston, Texas, Forenede Stater, 77074
      • Houston, Texas, Forenede Stater, 77090
      • Pasadena, Texas, Forenede Stater, 77504
      • San Antonio, Texas, Forenede Stater, 78229
      • San Antonio, Texas, Forenede Stater, 78258
      • San Antonio, Texas, Forenede Stater, 78215
      • Tyler, Texas, Forenede Stater, 75701
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
      • West Jordan, Utah, Forenede Stater, 84088
    • Virginia
      • Chesapeake, Virginia, Forenede Stater, 23320
      • Lynchburg, Virginia, Forenede Stater, 24502
    • Washington
      • Bellevue, Washington, Forenede Stater, 98004
      • Spokane, Washington, Forenede Stater, 99216
    • Wisconsin
      • West Bend, Wisconsin, Forenede Stater, 53095

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:

  • Confirmed IBS diagnosis per Rome II for diagnosis of IBS.
  • Colonoscopy within 2 years as part of IBS diagnostic evaluation.
  • Has active symptoms of non-constipation IBS at baseline as measured by average daily scores for abdominal pain/discomfort, bloating, and stool consistency.

Exclusion Criteria:

  • Symptoms of constipation.
  • History of other gastrointestinal diseases.
  • Type 1 or 2 diabetes.
  • Lactose intolerance not controlled by lactose-free diet.

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
Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Medicin: Placebo
Eksperimentel: Rifaximin
Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Medicin: Rifaximin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subjects Who Had Adequate Relief of Global IBS Symptoms for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
Tidsramme: 4 weeks
The primary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of global IBS symptoms was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subjects Who Had Adequate Relief of IBS-related Bloating for at Least 2 of the 4 Weeks During the Primary Evaluation Period (ie, Weeks 3 Through 6).
Tidsramme: 4 weeks
The secondary outcome measure is assessed during the 4-week period (ie, Weeks 3 through 6) immediately following 2 weeks of treatment with study drug. Adequate relief of bloating was defined as a response of "yes" to the following question, which was asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Bausch Health Americas, Inc.

Efterforskere

  • Studieleder: Enoch Bortey, Bausch Health Americas, 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. juli 2008

Primær færdiggørelse (Faktiske)

1. august 2009

Studieafslutning (Faktiske)

1. september 2009

Datoer for studieregistrering

Først indsendt

16. juli 2008

Først indsendt, der opfyldte QC-kriterier

8. august 2008

Først opslået (Skøn)

11. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RFIB3007

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Abonner