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

19. desember 2012 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

633

Fase

  • Fase 3

Kontakter og plasseringer

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

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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Forest Investigative Site
      • Birmingham, Alabama, Forente stater, 35215
        • Forest Investigative Site
      • Huntsville, Alabama, Forente stater, 35801
        • Forest Investigative Site
    • Arizona
      • Chandler, Arizona, Forente stater, 85225
        • Forest Investigative Site
      • Mesa, Arizona, Forente stater, 85210
        • Forest Investigative Site
      • Peoria, Arizona, Forente stater, 85381
        • Forest Investigative Site
      • Phoenix, Arizona, Forente stater, 85012
        • Forest Investigative Site
      • Scottsdale, Arizona, Forente stater, 85251
        • Forest Investigative Site
      • Tucson, Arizona, Forente stater, 85741
        • Forest Investigative Site
    • California
      • Burbank, California, Forente stater, 91505
        • Forest Investigative Site
      • Encinitas, California, Forente stater, 92024
        • Forest Investigative Site
      • Foothill Ranch, California, Forente stater, 92610
        • Forest Investigative Site
      • Los Angeles, California, Forente stater, 90036
        • Forest Investigative Site
      • Orange, California, Forente stater, 92869
        • Forest Investigative Site
      • Westlake Village, California, Forente stater, 91361
        • Forest Investigative Site
    • Colorado
      • Boulder, Colorado, Forente stater, 80304
        • Forest Investigative Site
      • Colorado Springs, Colorado, Forente stater, 80909
        • Forest Investigative Site
      • Denver, Colorado, Forente stater, 80205
        • Forest Investigative Sites
      • Longmont, Colorado, Forente stater, 80501
        • Forest Investigative Site
      • Wheat Ridge, Colorado, Forente stater, 80033
        • Forest Investigative Site
    • Connecticut
      • Waterbury, Connecticut, Forente stater, 06708
        • Forest Investigative Site
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Forest Investigative Site
      • Bradenton, Florida, Forente stater, 34203
        • Forest Investigative Site
      • Brooksville, Florida, Forente stater, 34601
        • Forest Investigative Site
      • Ft. Myers, Florida, Forente stater, 33916
        • Forest Investigative Site
      • Jupiter, Florida, Forente stater, 33458
        • Forest Investigative Site
      • Kissimmee, Florida, Forente stater, 34741
        • Forest Investigative Site
      • Miami, Florida, Forente stater, 33143
        • Forest Investigative Site
      • Ocala, Florida, Forente stater, 34471
        • Forest Investigative Site
      • Orlando, Florida, Forente stater, 32806
        • Forest Investigative Site
      • Panama City, Florida, Forente stater, 32405
        • Forest Investigative Site
      • Pembroke Pines, Florida, Forente stater, 33024
        • Forest Investigative Site
      • St. Petersburg, Florida, Forente stater, 33709
        • Forest Investigative Site
      • Tampa, Florida, Forente stater, 33606
        • Forest Investigative Site
      • Trinity, Florida, Forente stater, 34655
        • Forest Investigative Site
      • Zephyrhills, Florida, Forente stater, 33542
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Forest Investigative Site
      • Marietta, Georgia, Forente stater, 30060
        • Forest Investigative Site
      • Marietta, Georgia, Forente stater, 30067
        • Forest Investigative Site
      • Stockbridge, Georgia, Forente stater, 30281
        • Forest Investigative Site
      • Woodstock, Georgia, Forente stater, 30189
        • Forest Investigative Site
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • Forest Investigative Site
    • Illinois
      • Rockford, Illinois, Forente stater, 61107
        • Forest Investigative Site
    • Indiana
      • Elkhart, Indiana, Forente stater, 46514
        • Forest Investigative Site
      • Evansville, Indiana, Forente stater, 47714
        • Forest Investigative Site
      • Indianapolis, Indiana, Forente stater, 46237
        • Forest Investigative Site
      • Indianapolis, Indiana, Forente stater, 46254
        • Forest Investigative Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Forest Investigative Site
    • Kansas
      • Arkansas City, Kansas, Forente stater, 67005
        • Forest Investigative Site
      • Newton, Kansas, Forente stater, 67114
        • Forest Investigative Site
      • Wichita, Kansas, Forente stater, 67205
        • Forest Investigative Site
      • Wichita, Kansas, Forente stater, 67207
        • Forest Investigative Site
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40509
        • Forest Investigative Site
      • Madisonville, Kentucky, Forente stater, 42431
        • Forest Investigative Site
    • Maryland
      • Chevy Chase, Maryland, Forente stater, 20815
        • Forest Investigative Site
      • Hagerstown, Maryland, Forente stater, 21742
        • Forest Investigative Site
      • Lutherville, Maryland, Forente stater, 21093
        • Forest Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02135
        • Forest Investigative Site
    • Minnesota
      • Chaska, Minnesota, Forente stater, 55318
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, Forente stater, 63110
        • Forest Investigative Site
      • St. Louis, Missouri, Forente stater, 63128
        • Forest Investigative Site
    • New Jersey
      • Vineland, New Jersey, Forente stater, 08360
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Forest Investigative Site
    • New York
      • Brooklyn, New York, Forente stater, 11214
        • Forest Investigative Site
      • Great Neck, New York, Forente stater, 11021
        • Forest Investigative Site
      • Great Neck, New York, Forente stater, 11023
        • Forest Investigative Site
    • North Carolina
      • Fayetteville, North Carolina, Forente stater, 28304
        • Forest Investigative Site
      • Greensboro, North Carolina, Forente stater, 27403
        • Forest Investigative Site
      • Hickory, North Carolina, Forente stater, 28601
        • Forest Investigative Site
      • Raleigh, North Carolina, Forente stater, 27612
        • Forest Investigative Site
      • Wilmington, North Carolina, Forente stater, 28401
        • Forest Investigative Site
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Forest Investigative Site
    • North Dakota
      • Bismark, North Dakota, Forente stater, 58501
        • Forest Investigative Site
    • Ohio
      • Akron, Ohio, Forente stater, 44302
        • Forest Investigative Site
      • Cincinnati, Ohio, Forente stater, 45219
        • Forest Investigative Site
      • Cleveland, Ohio, Forente stater, 44122
        • Forest Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • Forest Investigative Site
      • Tulsa, Oklahoma, Forente stater, 74135
        • Forest Investigative Site
    • Pennsylvania
      • Bensalem, Pennsylvania, Forente stater, 19020
        • Forest Investigative Site
      • Pittsburgh, Pennsylvania, Forente stater, 15206
        • Forest Investigative Site
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29615
        • Forest Investigative Site
      • Greer, South Carolina, Forente stater, 29651
        • Forest Investigative Site
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37205
        • Forest Investigative Site
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Forest Investigative Site
      • Dallas, Texas, Forente stater, 75234
        • Forest Investigative Site
      • Houston, Texas, Forente stater, 77090
        • Forest Investigative Site
      • Lake Jackson, Texas, Forente stater, 77566
        • Forest Investigative Site
      • San Antonio, Texas, Forente stater, 78229
        • Forest Investigative Site
      • San Antonio, Texas, Forente stater, 78209
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, Forente stater, 84102
        • Forest Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22911
        • Forest Investigative Site
      • Christianburg, Virginia, Forente stater, 24073
        • Forest Investigative Site
      • Newport News, Virginia, Forente stater, 23606
        • Forest Investigative Site
      • Norfolk, Virginia, Forente stater, 23502
        • Forest Investigative Site
      • Norfolk, Virginia, Forente stater, 23507
        • Forest Investigative Site
      • Richmond, Virginia, Forente stater, 23294
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, Forente stater, 98402
        • Forest Investigative Site
      • Lakewood, Washington, Forente stater, 98499
        • Forest Investigative Site
      • Wenatchee, Washington, Forente stater, 98801
        • Forest Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Forest Investigative Site

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Linaclotide 290 micrograms
Legemiddel: Linaklotid 290 mikrogram
Oralt, en gang daglig hver morgen minst 30 minutter før frokost under hele studien
Eksperimentell: 2
Linaclotide 145 micrograms
Legemiddel: 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
Legemiddel: Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Forest Laboratories

Samarbeidspartnere

Ironwood Pharmaceuticals, Inc.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 2008

Primær fullføring (Faktiske)

1. juli 2009

Studiet fullført (Faktiske)

1. august 2009

Datoer for studieregistrering

Først innsendt

1. oktober 2008

Først innsendt som oppfylte QC-kriteriene

2. oktober 2008

Først lagt ut (Anslag)

3. oktober 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2012

Sist bekreftet

1. desember 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LIN-MD-01

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere