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

19. april 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Opioid-induceret obstipation

Intervention / Behandling

Medicin: Tegaserod

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Egypten
- - Egypt, Egypten
    - 6 Investigative Sites
Forenede Stater
- New Jersey
  - East Hanover, New Jersey, Forenede 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

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:

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

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: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis

Efterforskere

Ledende efterforsker: Novartis Pharmaceuticals Corp., NPC

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. februar 2007

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)