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Undersøgelse af kvinder med svær diarré-dominerende irritabel tyktarm, der har mislykket konventionel terapi

15. april 2015 opdateret af: GlaxoSmithKline

En 12-ugers, randomiseret, dobbeltblind, placebokontrolleret undersøgelse af PRN BID og faste doseringsregimer af alosetron hos kvindelige forsøgspersoner med svær diarré-prædominerende irritabel tyktarm, som har fejlet konventionel terapi

Formålet med denne undersøgelse er at sammenligne sikkerheden og effektiviteten af efter behov versus fast dosering af en forsøgsmedicin til kvinder med svær diarré-dominerende irritabel tyktarm (IBS), som har svigtet konventionel behandling.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Medicin: alosetron

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

700

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Australien
- Western Australia
  - Nedlands, Western Australia, Australien, 27408
    - GSK Investigational Site
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35235
    - GSK Investigational Site
  - Birmingham, Alabama, Forenede Stater, 35242
    - GSK Investigational Site
  - Huntsville, Alabama, Forenede Stater, 35801
    - GSK Investigational Site
  - Mobile, Alabama, Forenede Stater, 36693
    - GSK Investigational Site
  - Pell City, Alabama, Forenede Stater, 35125
    - GSK Investigational Site
  - Tallassee, Alabama, Forenede Stater, 36078
    - GSK Investigational Site
- Arizona
  - Tucson, Arizona, Forenede Stater, 85712
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - GSK Investigational Site
  - North Little Rock, Arkansas, Forenede Stater, 72117
    - GSK Investigational Site
- California
  - Beverly Hills, California, Forenede Stater, 90211
    - GSK Investigational Site
  - Carlsbad, California, Forenede Stater, 92008
    - GSK Investigational Site
  - Concord, California, Forenede Stater, 94520
    - GSK Investigational Site
  - Encinitas, California, Forenede Stater, 92024
    - GSK Investigational Site
  - Fresno, California, Forenede Stater, 93720
    - GSK Investigational Site
  - Garden Grove, California, Forenede Stater, 92840
    - GSK Investigational Site
  - Los Angeles, California, Forenede Stater, 90035
    - GSK Investigational Site
  - Orange, California, Forenede Stater, 92868
    - GSK Investigational Site
  - Roseville, California, Forenede Stater, 95661
    - GSK Investigational Site
  - San Diego, California, Forenede Stater, 92103
    - GSK Investigational Site
  - San Diego, California, Forenede Stater, 92120
    - GSK Investigational Site
  - San Diego, California, Forenede Stater, 92108
    - GSK Investigational Site
  - San Francisco, California, Forenede Stater, 94115
    - GSK Investigational Site
  - San Francisco, California, Forenede Stater, 94114
    - GSK Investigational Site
  - San Francisco, California, Forenede Stater, 94122
    - GSK Investigational Site
  - Santa Ana, California, Forenede Stater, 92704
    - GSK Investigational Site
  - Spring Valley, California, Forenede Stater, 91978
    - GSK Investigational Site
  - Torrance, California, Forenede Stater, 90505
    - GSK Investigational Site
  - Van Nuys, California, Forenede Stater, 91405
    - GSK Investigational Site
- Colorado
  - Centennial, Colorado, Forenede Stater, 80112
    - GSK Investigational Site
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - GSK Investigational Site
  - Littleton, Colorado, Forenede Stater, 80120
    - GSK Investigational Site
  - Longmont, Colorado, Forenede Stater, 80501
    - GSK Investigational Site
- Connecticut
  - Bristol, Connecticut, Forenede Stater, 06010
    - GSK Investigational Site
- Florida
  - Belleair Bluffs, Florida, Forenede Stater, 33770
    - GSK Investigational Site
  - Boca Raton, Florida, Forenede Stater, 33428
    - GSK Investigational Site
  - Bradenton, Florida, Forenede Stater, 34209
    - GSK Investigational Site
  - Clearwater, Florida, Forenede Stater, 33756
    - GSK Investigational Site
  - Clearwater, Florida, Forenede Stater, 33765
    - GSK Investigational Site
  - Deland, Florida, Forenede Stater, 32720
    - GSK Investigational Site
  - Gainesville, Florida, Forenede Stater, 32607
    - GSK Investigational Site
  - Hollywood, Florida, Forenede Stater, 33021
    - GSK Investigational Site
  - Jacksonville, Florida, Forenede Stater, 32256-6004
    - GSK Investigational Site
  - Jacksonville, Florida, Forenede Stater, 32209
    - GSK Investigational Site
  - Kissimmee, Florida, Forenede Stater, 34741
    - GSK Investigational Site
  - Melbourne, Florida, Forenede Stater, 32901
    - GSK Investigational Site
  - North Miami Beach, Florida, Forenede Stater, 33162
    - GSK Investigational Site
  - Spring Hill, Florida, Forenede Stater, 34608
    - GSK Investigational Site
  - Stuart, Florida, Forenede Stater, 34996
    - GSK Investigational Site
  - Zephyrhills, Florida, Forenede Stater, 33540
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30339
    - GSK Investigational Site
  - Atlanta, Georgia, Forenede Stater, 30328
    - GSK Investigational Site
  - Blue Ridge, Georgia, Forenede Stater, 30513
    - GSK Investigational Site
  - Dunwoody, Georgia, Forenede Stater, 30328
    - GSK Investigational Site
  - Fayetteville, Georgia, Forenede Stater, 30214
    - GSK Investigational Site
  - Rome, Georgia, Forenede Stater, 30165
    - GSK Investigational Site
  - Savannah, Georgia, Forenede Stater, 31405
    - GSK Investigational Site
- Idaho
  - Boise, Idaho, Forenede Stater, 83702
    - GSK Investigational Site
  - Coeur D'Alene, Idaho, Forenede Stater, 83814
    - GSK Investigational Site
  - Meridian, Idaho, Forenede Stater, 83642
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60637
    - GSK Investigational Site
  - Chicago, Illinois, Forenede Stater, 60612-7323
    - GSK Investigational Site
  - Libertyville, Illinois, Forenede Stater, 60048
    - GSK Investigational Site
  - Moline, Illinois, Forenede Stater, 61265
    - GSK Investigational Site
  - Morton Grove, Illinois, Forenede Stater, 61550
    - GSK Investigational Site
  - Oakbrook Terrace, Illinois, Forenede Stater, 60181
    - GSK Investigational Site
  - Peoria, Illinois, Forenede Stater, 61602
    - GSK Investigational Site
  - Rockford, Illinois, Forenede Stater, 61107
    - GSK Investigational Site
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46237
    - GSK Investigational Site
  - Indianapolis, Indiana, Forenede Stater, 46208
    - GSK Investigational Site
  - Jeffersonville, Indiana, Forenede Stater, 47130
    - GSK Investigational Site
- Iowa
  - Clive, Iowa, Forenede Stater, 50325
    - GSK Investigational Site
- Kansas
  - Haysville, Kansas, Forenede Stater, 67060
    - GSK Investigational Site
  - Kansas City, Kansas, Forenede Stater, 66160
    - GSK Investigational Site
  - Wichita, Kansas, Forenede Stater, 67203
    - GSK Investigational Site
- Kentucky
  - Florence, Kentucky, Forenede Stater, 41042
    - GSK Investigational Site
  - Lexington, Kentucky, Forenede Stater, 40536
    - GSK Investigational Site
  - Lexington, Kentucky, Forenede Stater, 40508
    - GSK Investigational Site
  - Madisonville, Kentucky, Forenede Stater, 42431
    - GSK Investigational Site
- Louisiana
  - Covington, Louisiana, Forenede Stater, 70433
    - GSK Investigational Site
  - Lafayette, Louisiana, Forenede Stater, 70508
    - GSK Investigational Site
  - Monroe, Louisiana, Forenede Stater, 71201
    - GSK Investigational Site
  - New Orleans, Louisiana, Forenede Stater, 70112
    - GSK Investigational Site
  - New Orleans, Louisiana, Forenede Stater, 70128
    - GSK Investigational Site
  - Shreveport, Louisiana, Forenede Stater, 71103
    - GSK Investigational Site
- Maryland
  - Annapolis, Maryland, Forenede Stater, 21401
    - GSK Investigational Site
  - Baltimore, Maryland, Forenede Stater, 21229
    - GSK Investigational Site
  - Baltimore, Maryland, Forenede Stater, 21215
    - GSK Investigational Site
  - Lanham, Maryland, Forenede Stater, 20706
    - GSK Investigational Site
  - Oxon Hill, Maryland, Forenede Stater, 20745
    - GSK Investigational Site
  - Severna Park, Maryland, Forenede Stater, 21146
    - GSK Investigational Site
  - Silver Spring, Maryland, Forenede Stater, 20910
    - GSK Investigational Site
  - Towson, Maryland, Forenede Stater, 21204
    - GSK Investigational Site
  - Towson, Maryland, Forenede Stater, 21204-7736
    - GSK Investigational Site
  - Wheaton, Maryland, Forenede Stater, 20906
    - GSK Investigational Site
- Massachusetts
  - Burlington, Massachusetts, Forenede Stater, 01805
    - GSK Investigational Site
- Michigan
  - Farmington Hills, Michigan, Forenede Stater, 48334
    - GSK Investigational Site
  - Northville, Michigan, Forenede Stater, 48167
    - GSK Investigational Site
  - Petoskey, Michigan, Forenede Stater, 49770
    - GSK Investigational Site
  - Saginaw, Michigan, Forenede Stater, 48602
    - GSK Investigational Site
- Minnesota
  - Brooklyn Center, Minnesota, Forenede Stater, 55430
    - GSK Investigational Site
- Missouri
  - Chesterfield, Missouri, Forenede Stater, 63017
    - GSK Investigational Site
  - St. Louis, Missouri, Forenede Stater, 63141
    - GSK Investigational Site
- Nebraska
  - Lincoln, Nebraska, Forenede Stater, 68503
    - GSK Investigational Site
  - Omaha, Nebraska, Forenede Stater, 68144
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89119
    - GSK Investigational Site
- New Jersey
  - Berlin, New Jersey, Forenede Stater, 08009
    - GSK Investigational Site
  - Blackwood, New Jersey, Forenede Stater, 08012
    - GSK Investigational Site
  - Cedar Knolls, New Jersey, Forenede Stater, 7927
    - GSK Investigational Site
  - Oakhurst, New Jersey, Forenede Stater, 07755
    - GSK Investigational Site
  - Passaic, New Jersey, Forenede Stater, 07055
    - GSK Investigational Site
  - South Bound Brook, New Jersey, Forenede Stater, 08880
    - GSK Investigational Site
  - Willingboro, New Jersey, Forenede Stater, 08046
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87106
    - GSK Investigational Site
- New York
  - Albany, New York, Forenede Stater, 12205
    - GSK Investigational Site
  - Binghamton, New York, Forenede Stater, 13901
    - GSK Investigational Site
  - Endwell, New York, Forenede Stater, 13760
    - GSK Investigational Site
  - Great Neck, New York, Forenede Stater, 11023
    - GSK Investigational Site
  - Pittsford, New York, Forenede Stater, 14534
    - GSK Investigational Site
  - Pomona, New York, Forenede Stater, 10970
    - GSK Investigational Site
- North Carolina
  - Cary, North Carolina, Forenede Stater, 27511
    - GSK Investigational Site
  - Charlotte, North Carolina, Forenede Stater, 28262
    - GSK Investigational Site
  - Gastonia, North Carolina, Forenede Stater, 28054
    - GSK Investigational Site
  - Greensboro, North Carolina, Forenede Stater, 27403
    - GSK Investigational Site
  - Greenville, North Carolina, Forenede Stater, 27858
    - GSK Investigational Site
  - Jacksonville, North Carolina, Forenede Stater, 28546
    - GSK Investigational Site
  - Raleigh, North Carolina, Forenede Stater, 27609
    - GSK Investigational Site
  - Wilmington, North Carolina, Forenede Stater, 28401
    - GSK Investigational Site
  - Wilmington, North Carolina, Forenede Stater, 28412
    - GSK Investigational Site
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - GSK Investigational Site
- Ohio
  - Bellbrook, Ohio, Forenede Stater, 45305
    - GSK Investigational Site
  - Cincinnati, Ohio, Forenede Stater, 45236
    - GSK Investigational Site
  - Columbus, Ohio, Forenede Stater, 43215
    - GSK Investigational Site
  - Columbus, Ohio, Forenede Stater, 43207
    - GSK Investigational Site
  - Wandsworth, Ohio, Forenede Stater, 44281
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73112
    - GSK Investigational Site
  - Tulsa, Oklahoma, Forenede Stater, 74135
    - GSK Investigational Site
- Oregon
  - Portland, Oregon, Forenede Stater, 97225
    - GSK Investigational Site
  - Portland, Oregon, Forenede Stater, 97210
    - GSK Investigational Site
- Pennsylvania
  - Bensalem, Pennsylvania, Forenede Stater, 19020
    - GSK Investigational Site
  - Duncansville, Pennsylvania, Forenede Stater, 16635
    - GSK Investigational Site
  - Feasterville, Pennsylvania, Forenede Stater, 19053
    - GSK Investigational Site
  - Levittown, Pennsylvania, Forenede Stater, 19057
    - GSK Investigational Site
  - Media, Pennsylvania, Forenede Stater, 19063
    - GSK Investigational Site
  - Morrisville, Pennsylvania, Forenede Stater, 19067
    - GSK Investigational Site
  - Penndel, Pennsylvania, Forenede Stater, 19047
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19107
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19106
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19148
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, Forenede Stater, 15218
    - GSK Investigational Site
  - Reading, Pennsylvania, Forenede Stater, 19611
    - GSK Investigational Site
  - Sellersville, Pennsylvania, Forenede Stater, 18960
    - GSK Investigational Site
  - Stoneboro, Pennsylvania, Forenede Stater, 16153
    - GSK Investigational Site
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - GSK Investigational Site
  - Charleston, South Carolina, Forenede Stater, 29407
    - GSK Investigational Site
  - Summerville, South Carolina, Forenede Stater, 29485
    - GSK Investigational Site
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, Forenede Stater, 37620
    - GSK Investigational Site
  - Clarksville, Tennessee, Forenede Stater, 37043
    - GSK Investigational Site
  - Jackson, Tennessee, Forenede Stater, 38305
    - GSK Investigational Site
  - Johnson City, Tennessee, Forenede Stater, 37601
    - GSK Investigational Site
  - Kingsport, Tennessee, Forenede Stater, 37660
    - GSK Investigational Site
  - Knoxville, Tennessee, Forenede Stater, 37920
    - GSK Investigational Site
  - Memphis, Tennessee, Forenede Stater, 38119
    - GSK Investigational Site
  - Nashville, Tennessee, Forenede Stater, 37205
    - GSK Investigational Site
- Texas
  - Austin, Texas, Forenede Stater, 78758
    - GSK Investigational Site
  - Conroe, Texas, Forenede Stater, 77304
    - GSK Investigational Site
  - Dallas, Texas, Forenede Stater, 75230
    - GSK Investigational Site
  - Houston, Texas, Forenede Stater, 77024
    - GSK Investigational Site
  - Humble, Texas, Forenede Stater, 77338
    - GSK Investigational Site
  - North Richland Hills, Texas, Forenede Stater, 76180
    - GSK Investigational Site
  - Pasadena, Texas, Forenede Stater, 77505
    - GSK Investigational Site
  - San Antonio, Texas, Forenede Stater, 78229
    - GSK Investigational Site
  - San Antonio, Texas, Forenede Stater, 78205
    - GSK Investigational Site
  - Sugar Land, Texas, Forenede Stater, 77478
    - GSK Investigational Site
  - Woodlands, Texas, Forenede Stater, 77381
    - GSK Investigational Site
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84132
    - GSK Investigational Site
- Virginia
  - Chesapeake, Virginia, Forenede Stater, 23320
    - GSK Investigational Site
  - Christiansburg, Virginia, Forenede Stater, 24073
    - GSK Investigational Site
  - Danville, Virginia, Forenede Stater, 24541
    - GSK Investigational Site
  - Norfolk, Virginia, Forenede Stater, 23502
    - GSK Investigational Site
  - Norfolk, Virginia, Forenede Stater, 23507
    - GSK Investigational Site
  - Richmond, Virginia, Forenede Stater, 23294
    - GSK Investigational Site
  - Virginia Beach, Virginia, Forenede Stater, 23455
    - GSK Investigational Site
  - Weber City, Virginia, Forenede Stater, 24290
    - GSK Investigational Site
- Washington
  - Bellevue, Washington, Forenede Stater, 98004
    - GSK Investigational Site
  - Gig Harbor, Washington, Forenede Stater, 98335
    - GSK Investigational Site
  - Lacey, Washington, Forenede Stater, 98516
    - GSK Investigational Site
  - Tacoma, Washington, Forenede Stater, 98405
    - GSK Investigational Site
- Wisconsin
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - GSK Investigational Site
  - Madison, Wisconsin, Forenede Stater, 53792
    - GSK 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

Kvinde

Beskrivelse

Inklusionskriterier:

Diagnosticeret med svær diarré-dominerende irritabel tyktarm (IBS).
Mislykket konventionel terapi.
Villig til at foretage daglige opkald på en touch-tone telefon.

Eksklusionskriterier:

Anamnese med eller aktuel kronisk eller svær forstoppelse.
Blodig diarré, mavesmerter med rektal blødning.
Tromboflebitis.
Unormal værdi for thyreoideastimulerende hormon (TSH).
Alkohol- og/eller stofmisbrug inden for de seneste to år.
Gravid eller ammende.
Anamnese/behandling af malignitet inden for de seneste fem år.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Emnet selvvurdering af forbedring mellem behandlingsgrupper ved hjælp af IBS Global Improvement Scale; sammenligning af sikkerhed og tolerabilitet mellem behandlingsgrupper med hensyn til uønskede hændelser og laboratorieabnormiteter. Tidsramme: 12 uger	12 uger

Sekundære resultatmål

Resultatmål	Tidsramme
Sammenligning af behandlingsgrupper med hensyn til forsøgspersons lindring af IBS smerter og ubehag; lavere GI-symptomer, ændringer i livskvalitet, tabt produktivitet på arbejdspladsen og mistet husholdnings-/fritidsaktivitet og forsøgspersonens tilfredshed med tildelt studielægemiddel. Tidsramme: 12 uger	12 uger

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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. juni 2003

Primær færdiggørelse (Faktiske)

1. december 2005

Studieafslutning (Faktiske)

1. december 2005

Datoer for studieregistrering

Først indsendt

20. august 2003

Først indsendt, der opfyldte QC-kriterier