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

19 dicembre 2012 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

633

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 1
Linaclotide 290 micrograms
Droga: Linaclotide 290 microgrammi
Orale, una volta al giorno ogni mattina almeno 30 minuti prima di colazione per tutta la durata dello studio
Sperimentale: 2
Linaclotide 145 micrograms
Droga: Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Comparatore placebo: 3
Matching placebo
Droga: Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Forest Laboratories

Collaboratori

Ironwood Pharmaceuticals, Inc.

Investigatori

  • Direttore dello studio: Paul F.C. Eng, PhD, Forest Laboratories

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2008

Completamento primario (Effettivo)

1 luglio 2009

Completamento dello studio (Effettivo)

1 agosto 2009

Date di iscrizione allo studio

Primo inviato

1 ottobre 2008

Primo inviato che soddisfa i criteri di controllo qualità

2 ottobre 2008

Primo Inserito (Stima)

3 ottobre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 dicembre 2012

Ultimo verificato

1 dicembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LIN-MD-01

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

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