Etude : NACASY /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : NACASY

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/06/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

Spécialité : Toutes tumeurs solides
Localisation : C - Toutes localisations
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

The primary safety end point is the incidence of adverse events leading to study discontinuation.

The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.

Phase : NA

Stade : Localisé à Métastatique

1, 2, 3, 4, X
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patient ≥ 18 years old
- Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
- Patient with opioid-induced constipation
- Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
- Signing of the informed consent

Critères de non-inclusion : Patients with colorectal cancer
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03638440
Promoteur :
KYOWA KIRIN PHARMA
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier de Valenciennes - Avenue Désandrouin - CS 50479 - 59300 VALENCIENNES

Investigateur :
Docteur Antoine LEMAIRE

TEC / ARC / IDE :
Madame Marielle FERY
fery-m@
ch-valenciennes.fr
03 27 14 07 15

Ouverture de l'essai : OUVERT

MAJ : 28/06/2019