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

19. april 2012 oppdatert av: Novartis

An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain

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

Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:

Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.

Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:

Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.

Studieoversikt

Status

Avsluttet

Forhold

Opioid-indusert forstoppelse

Intervensjon / Behandling

Legemiddel: Tegaserod

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 3

Kontakter og plasseringer

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

Studiesteder

Egypt
- - Egypt, Egypt
    - 6 Investigative Sites
Forente stater
- New Jersey
  - East Hanover, New Jersey, Forente stater
    - 60 Investigative Sites
Kina
- - Hong Kong, Kina
    - 2 Investigative Sites
Singapore
- - Singapore, Singapore
    - 1 Investigative Site
Taiwan
- - Taiwan, Taiwan
    - 2 Investigative Sites
Venezuela
- - Venezuela, Venezuela
    - 4 Investigative Sites

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

N/A

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Male and female outpatients 18 years of age or older.
Patients with chronic non-cancer pain that necessitates the use of non- injectable opioid analgesics.
Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
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:

Hard or very hard stools
sensation of incomplete evacuation
straining while having a bowel movement

Exclusion Criteria:

1. Who are receiving opioids for abdominal pain or connective tissue disorders.
Planned discontinuation of opioids during the study
Who underwent major surgery within 3 months prior to screening.
With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
With a previous use of tegaserod within 3 months prior to baseline.

Other protocol-defined inclusion/exclusion criteria may apply

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: Ikke-randomisert
Intervensjonsmodell: Enkeltgruppeoppdrag
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
To evaluate the long term safety of tegaserod

Sekundære resultatmål

Resultatmål
Change from baseline assessment of OIC symptoms at weeks 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis

Etterforskere

Hovedetterforsker: Novartis Pharmaceuticals Corp., NPC

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. februar 2007

Primær fullføring (Faktiske)

1. mai 2007

Studiet fullført (Faktiske)