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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01234168
Other study ID # 8-79-52030-736
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2010
Est. completion date December 2012

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Out-patients 18 years of age and older, who have agreed to participate in the study - Diagnosed with a Neuroendocrine tumour (NET) and receiving treatment with Somatuline Autogel Exclusion Criteria: - Subjects for whom there are reasons that may hinder the conduct of the study (patients who have difficulty expressing themselves or who are unable to complete the questionnaires, or with insufficient data in the their files will not be enrolled in the study).

Study Design


Locations

Country Name City State
Czechia Teaching Hospital Brno Bohunice Brno
Czechia University Hospital Hradec Kralove Hradec Kralove
Czechia Hospital Pardubice Pardubice
Czechia Teaching Hospital Plzen
Czechia Charles University Praha
Czechia Teaching Hospital Na Bulovce Praha
France CHU Angers Angers
France Hôpital Avicenne Bobigny
France Hôpital Saint André Bordeaux
France CHU Trousseau Chambray Les Tours
France Hôpital Beaujon Clichy
France CHU Michallon Grenoble
France Hôpital Edouard Herriot Lyon
France CHU Timone Marseille
France Hôpital Archet 2 Nice
France Hôpital du Haut Leveque Pessac
France Hôpital Robert Debré Reims
France CHU St Etienne Saint Priest
France Hôpital Rangueil Toulouse
France Institut Gustave-Roussy Villejuif
Hungary Semmelweis University Budapest
Hungary Karádi-Nagy Bt. Pécs
Israel Hadasit Medical Research Jerusalem
Italy Ospedale Regina Apostolorum Albano Laziale
Italy Ospedale Pesenti Fenaroli Alzano Lombardo
Italy Ospedale Civile Castelfranco Veneto
Italy Università degli Studi di Chieti Chieti
Italy Istituti Ospedalieri di Cremona Cremona
Italy Azienda Ospedaliera-Universitaria Policlinico Modena
Italy U.O.C. Malattie dell'Apparato Digerente e del Fegato Roma
Italy Unità di Endocrinologia Istituti Fisioterapici Ospitalieri Roma
Italy Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy Istituto Oncologico del Mediterraneo Viagrande
Poland Szpital Uniwersytecki im. A. Jurasza Bydgoszcz
Poland Slaskiego Uniwersytetu Medycznego Katowice
Poland Szpital Uniwersytecki w Krakowie Krakow
Poland Szpital Uniwersytecki w Lodzi Lodz
Poland Prywatna Praktyka Lekarska Olsztyn
Poland Specjalistyczny Gabinet Lekarski Poznan
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 Szczecin
Poland Niepubliczny Zaklad Opieki Zdrowotnej Warszawa
Poland Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Warszawa
Poland Wojskowy Instytut Medyczny Warszawa
Spain Hospital De Cruces Barakaldo
Spain Hospital Universitari de Bellvitge Barcelona
Spain Hospital General Reina Sofia Cordoba
Spain Hospital Clinico Universitario de Santiago La Coruña
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Xeral Cies de Vigo Pontevedra
Spain Hospital Virgen Macarena Sevilla
Spain Hospital Universitario Miguel Servet Zaragoza
United Kingdom University Hospital of Wales Cardiff
United Kingdom University Hospital Coventry
United Kingdom University Hospital Aintree Liverpool
United Kingdom Royal Free Hospital London
United Kingdom Chrisite Hospital Institute Manchester
United Kingdom Freeman Hospital Newcastle upon Tyne

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  France,  Hungary,  Israel,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subject's overall satisfaction regarding control of diarrhea Use of questionnaires to assess patient satisfaction (Likert scale). Day of survey
Secondary Impact on daily activities of the clinical manifestations of diarrhea Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S). Day of survey
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