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Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

19. december 2012 opdateret af: Forest Laboratories

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

633

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V67 2K5
        • Forest Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Forest Investigative Site
      • Newmarket, Ontario, Canada, L3Y 7V1
        • Forest Investigative Site
      • Ottawa, Ontario, Canada, K2c 3R2
        • Forest Investigative Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Forest Investigative Site 1
      • Sarnia, Ontario, Canada, N7T 4X3
        • Forest Investigative Site 2
      • Sudbury, Ontario, Canada, P3E 1H5
        • Forest Investigative Site
      • Toronto, Ontario, Canada, MCN 2V7
        • Forest Investigative Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • Forest Investigative Site
      • Birmingham, Alabama, Forenede Stater, 35215
        • Forest Investigative Site
      • Huntsville, Alabama, Forenede Stater, 35801
        • Forest Investigative Site
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Forest Investigative Site
      • Mesa, Arizona, Forenede Stater, 85210
        • Forest Investigative Site
      • Peoria, Arizona, Forenede Stater, 85381
        • Forest Investigative Site
      • Phoenix, Arizona, Forenede Stater, 85012
        • Forest Investigative Site
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Forest Investigative Site
      • Tucson, Arizona, Forenede Stater, 85741
        • Forest Investigative Site
    • California
      • Burbank, California, Forenede Stater, 91505
        • Forest Investigative Site
      • Encinitas, California, Forenede Stater, 92024
        • Forest Investigative Site
      • Foothill Ranch, California, Forenede Stater, 92610
        • Forest Investigative Site
      • Los Angeles, California, Forenede Stater, 90036
        • Forest Investigative Site
      • Orange, California, Forenede Stater, 92869
        • Forest Investigative Site
      • Westlake Village, California, Forenede Stater, 91361
        • Forest Investigative Site
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Forest Investigative Site
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Forest Investigative Site
      • Denver, Colorado, Forenede Stater, 80205
        • Forest Investigative Sites
      • Longmont, Colorado, Forenede Stater, 80501
        • Forest Investigative Site
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Forest Investigative Site
    • Connecticut
      • Waterbury, Connecticut, Forenede Stater, 06708
        • Forest Investigative Site
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Forest Investigative Site
      • Bradenton, Florida, Forenede Stater, 34203
        • Forest Investigative Site
      • Brooksville, Florida, Forenede Stater, 34601
        • Forest Investigative Site
      • Ft. Myers, Florida, Forenede Stater, 33916
        • Forest Investigative Site
      • Jupiter, Florida, Forenede Stater, 33458
        • Forest Investigative Site
      • Kissimmee, Florida, Forenede Stater, 34741
        • Forest Investigative Site
      • Miami, Florida, Forenede Stater, 33143
        • Forest Investigative Site
      • Ocala, Florida, Forenede Stater, 34471
        • Forest Investigative Site
      • Orlando, Florida, Forenede Stater, 32806
        • Forest Investigative Site
      • Panama City, Florida, Forenede Stater, 32405
        • Forest Investigative Site
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Forest Investigative Site
      • St. Petersburg, Florida, Forenede Stater, 33709
        • Forest Investigative Site
      • Tampa, Florida, Forenede Stater, 33606
        • Forest Investigative Site
      • Trinity, Florida, Forenede Stater, 34655
        • Forest Investigative Site
      • Zephyrhills, Florida, Forenede Stater, 33542
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Forest Investigative Site
      • Marietta, Georgia, Forenede Stater, 30060
        • Forest Investigative Site
      • Marietta, Georgia, Forenede Stater, 30067
        • Forest Investigative Site
      • Stockbridge, Georgia, Forenede Stater, 30281
        • Forest Investigative Site
      • Woodstock, Georgia, Forenede Stater, 30189
        • Forest Investigative Site
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Forest Investigative Site
    • Illinois
      • Rockford, Illinois, Forenede Stater, 61107
        • Forest Investigative Site
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46514
        • Forest Investigative Site
      • Evansville, Indiana, Forenede Stater, 47714
        • Forest Investigative Site
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Forest Investigative Site
      • Indianapolis, Indiana, Forenede Stater, 46254
        • Forest Investigative Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Forest Investigative Site
    • Kansas
      • Arkansas City, Kansas, Forenede Stater, 67005
        • Forest Investigative Site
      • Newton, Kansas, Forenede Stater, 67114
        • Forest Investigative Site
      • Wichita, Kansas, Forenede Stater, 67205
        • Forest Investigative Site
      • Wichita, Kansas, Forenede Stater, 67207
        • Forest Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Forest Investigative Site
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Forest Investigative Site
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Forest Investigative Site
      • Hagerstown, Maryland, Forenede Stater, 21742
        • Forest Investigative Site
      • Lutherville, Maryland, Forenede Stater, 21093
        • Forest Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02135
        • Forest Investigative Site
    • Minnesota
      • Chaska, Minnesota, Forenede Stater, 55318
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • Forest Investigative Site
      • St. Louis, Missouri, Forenede Stater, 63128
        • Forest Investigative Site
    • New Jersey
      • Vineland, New Jersey, Forenede Stater, 08360
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • Forest Investigative Site
    • New York
      • Brooklyn, New York, Forenede Stater, 11214
        • Forest Investigative Site
      • Great Neck, New York, Forenede Stater, 11021
        • Forest Investigative Site
      • Great Neck, New York, Forenede Stater, 11023
        • Forest Investigative Site
    • North Carolina
      • Fayetteville, North Carolina, Forenede Stater, 28304
        • Forest Investigative Site
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Forest Investigative Site
      • Hickory, North Carolina, Forenede Stater, 28601
        • Forest Investigative Site
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Forest Investigative Site
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Forest Investigative Site
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Forest Investigative Site
    • North Dakota
      • Bismark, North Dakota, Forenede Stater, 58501
        • Forest Investigative Site
    • Ohio
      • Akron, Ohio, Forenede Stater, 44302
        • Forest Investigative Site
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Forest Investigative Site
      • Cleveland, Ohio, Forenede Stater, 44122
        • Forest Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Forest Investigative Site
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Forest Investigative Site
    • Pennsylvania
      • Bensalem, Pennsylvania, Forenede Stater, 19020
        • Forest Investigative Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15206
        • Forest Investigative Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29615
        • Forest Investigative Site
      • Greer, South Carolina, Forenede Stater, 29651
        • Forest Investigative Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • Forest Investigative Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Forest Investigative Site
      • Dallas, Texas, Forenede Stater, 75234
        • Forest Investigative Site
      • Houston, Texas, Forenede Stater, 77090
        • Forest Investigative Site
      • Lake Jackson, Texas, Forenede Stater, 77566
        • Forest Investigative Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Forest Investigative Site
      • San Antonio, Texas, Forenede Stater, 78209
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84102
        • Forest Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22911
        • Forest Investigative Site
      • Christianburg, Virginia, Forenede Stater, 24073
        • Forest Investigative Site
      • Newport News, Virginia, Forenede Stater, 23606
        • Forest Investigative Site
      • Norfolk, Virginia, Forenede Stater, 23502
        • Forest Investigative Site
      • Norfolk, Virginia, Forenede Stater, 23507
        • Forest Investigative Site
      • Richmond, Virginia, Forenede Stater, 23294
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, Forenede Stater, 98402
        • Forest Investigative Site
      • Lakewood, Washington, Forenede Stater, 98499
        • Forest Investigative Site
      • Wenatchee, Washington, Forenede Stater, 98801
        • Forest Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Forest Investigative 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 has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
  • Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient demonstrates continued chronic constipation through Pretreatment Period
  • Patient is compliant with IVRS

Exclusion Criteria:

  • Patient has history of loose or watery stools
  • Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

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
Eksperimentel: 1
Linaclotide 290 micrograms
Medicin: Linaclotide 290 mikrogram
Oral, én gang dagligt hver morgen mindst 30 minutter før morgenmad i hele undersøgelsens varighed
Eksperimentel: 2
Linaclotide 145 micrograms
Medicin: Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Placebo komparator: 3
Matching placebo
Medicin: Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Tidsramme: Change from Baseline to Week 12

A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.

A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.

An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Change from Baseline to Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Tidsramme: Change from Baseline to Week 12
The number of CSBMs per week.
Change from Baseline to Week 12
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
Tidsramme: Change from Baseline to Week 12
A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.
Change from Baseline to Week 12
12-Week Stool Consistency
Tidsramme: Change from Baseline to Week 12

The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:

  1. = separate hard lumps like nuts [difficult to pass]
  2. = sausage shaped but lumpy
  3. = like a sausage but with cracks on surface
  4. = like a sausage or snake, smooth and soft
  5. = soft blobs with clear-cut edges [passed easily]
  6. = fluffy pieces with ragged edges, a mushy stool
  7. = watery, no solid pieces [entirely liquid]
Change from Baseline to Week 12
12-Week Severity of Straining
Tidsramme: Change from Baseline to Week 12
Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.
Change from Baseline to Week 12
12-Week Abdominal Discomfort
Tidsramme: Change from Baseline to Week 12
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Change from Baseline to Week 12
12-Week Bloating
Tidsramme: Change from Baseline to Week 12
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to Week 12
12-Week Constipation Severity
Tidsramme: Change from Baseline to Week 12
Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to Week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Forest Laboratories

Samarbejdspartnere

Ironwood Pharmaceuticals, Inc.

Efterforskere

  • Studieleder: Paul F.C. Eng, PhD, Forest Laboratories

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. september 2008

Primær færdiggørelse (Faktiske)

1. juli 2009

Studieafslutning (Faktiske)

1. august 2009

Datoer for studieregistrering

Først indsendt

1. oktober 2008

Først indsendt, der opfyldte QC-kriterier

2. oktober 2008

Først opslået (Skøn)

3. oktober 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2012

Sidst verificeret

1. december 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LIN-MD-01

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 Kronisk forstoppelse

Kliniske forsøg med Linaclotide 290 mikrogram

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner