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Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain

19. april 2012 opdateret af: Novartis

A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

670

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Investigative Site
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85029
        • Investigative Site
      • Phoenix, Arizona, Forenede Stater, 85050
        • Investigative Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Investigative Site
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Investigative Site
    • California
      • Buena Park, California, Forenede Stater, 90620
        • Investigative Site
      • Downey, California, Forenede Stater, 90240
        • Investigative Site
      • Encinitas, California, Forenede Stater, 92024
        • Investigative Site
      • Fountain Valley, California, Forenede Stater, 92708
        • Investigative Site
      • La Jolla, California, Forenede Stater, 92037
        • Investigative Site
      • Los Angeles, California, Forenede Stater, 90073
        • Investigative Site
      • Mission Viejo, California, Forenede Stater, 92691
        • Investigative Site
      • San Diego, California, Forenede Stater, 92103
        • Investigative Site
      • San Francisco, California, Forenede Stater, 94115
        • Investigative Site
      • Torrance, California, Forenede Stater, 90505
        • Investigative Site
    • Colorado
      • Northglenn, Colorado, Forenede Stater, 80234
        • Investigative Site
    • Connecticut
      • Bristol, Connecticut, Forenede Stater, 06010
        • Investigative Site
    • Florida
      • DeLand, Florida, Forenede Stater, 32720
        • Investigative Site
      • Jacksonville, Florida, Forenede Stater, 32207
        • Investigative Site
      • Largo, Florida, Forenede Stater, 33773
        • Investigative Site
      • Miami, Florida, Forenede Stater, 33176
        • Investigative Site
      • New Smyrna Beach, Florida, Forenede Stater, 32168
        • Investigative Site
      • Springhill, Florida, Forenede Stater, 34609
        • Investigative Site
      • Tampa, Florida, Forenede Stater, 33607
        • Investigative Site
    • Illinois
      • Belleville, Illinois, Forenede Stater, 62220
        • Investigative Site
      • Chicago, Illinois, Forenede Stater, 60640
        • Investigative Site
    • Indiana
      • Avon, Indiana, Forenede Stater, 46123
        • Investigative Site
      • Evansville, Indiana, Forenede Stater, 47714
        • Investigative Site
      • Indianapolis, Indiana, Forenede Stater, 46254
        • Investigative Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66212
        • Investigative Site
      • Prairie Village, Kansas, Forenede Stater, 66206
        • Investigative Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71103
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Investigative Site
      • Boston, Massachusetts, Forenede Stater, 02215
        • Investigative Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68114
        • Investigative Site
      • Omaha, Nebraska, Forenede Stater, 68134
        • Investigative Site
    • Nevada
      • Pahrump, Nevada, Forenede Stater, 89048
        • Investigative Site
    • New Jersey
      • East Hanover, New Jersey, Forenede Stater, 07936-1080
        • Novartis Pharmaceutical Corporation
    • New York
      • New York, New York, Forenede Stater, 10016
        • Investigative Site
      • New York City, New York, Forenede Stater, 10022
        • Investigative Site
      • North Massapequa, New York, Forenede Stater, 11758
        • Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Investigative Site
      • Greensboro, North Carolina, Forenede Stater, 27401
        • Investigative Site
      • Monroe, North Carolina, Forenede Stater, 28112
        • Investigative Site
      • Winston Salem, North Carolina, Forenede Stater, 27103
        • Investigative Site
    • Ohio
      • Dayton, Ohio, Forenede Stater, 45440
        • Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Investigative Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97232
        • Investigative Site
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-085
        • Investigative Site
      • Levittown, Pennsylvania, Forenede Stater, 19056
        • Investigative Site
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Investigative Site
    • Texas
      • Beaumont, Texas, Forenede Stater, 77701
        • Investigative Site
      • Colleyville, Texas, Forenede Stater, 76034
        • Investigative Site
      • Corsicana, Texas, Forenede Stater, 75110
        • Investigative Site
      • Houston, Texas, Forenede Stater, 77005
        • Investigative Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Investigative Site
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84132
        • Investigative Site
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Investigative Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • 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

N/A

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Male and female outpatients 18 years of age or older.
  2. Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
  3. Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.

  4. Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:

    • less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:

      1. hard or very hard stools
      2. sensation of incomplete evacuation
      3. straining while having a bowel movement

Exclusion Criteria:

  1. Patients who are receiving opioids for abdominal pain or connective tissue disorders.
  2. Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
  3. Patients who underwent major surgery within 3 months prior to screening.
  4. Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
  5. Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.

Other protocol-defined inclusion/exclusion criteria may apply.

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
Change from baseline in the number of bowel movements over weeks 1-4

Sekundære resultatmål

Resultatmål
Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis

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 2006

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

17. august 2006

Først indsendt, der opfyldte QC-kriterier

17. august 2006

Først opslået (Skøn)

18. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. april 2012

Sidst verificeret

1. april 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHTF919N2201

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 Tegaserod

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner