NCT01234168

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
8 countries

57 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

October 20, 2010

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Subject's overall satisfaction regarding control of diarrhea

    Use of questionnaires to assess patient satisfaction (Likert scale).

    Day of survey

Secondary Outcomes (1)

  • Impact on daily activities of the clinical manifestations of diarrhea

    Day of survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Out-patients

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

Teaching Hospital Brno Bohunice

Brno, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location

Hospital Pardubice

Pardubice, Czechia

Location

Teaching Hospital

Pilsen, Czechia

Location

Charles University

Prague, Czechia

Location

Teaching Hospital Na Bulovce

Prague, Czechia

Location

CHU Angers

Angers, 49933, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

Hôpital Saint André

Bordeaux, 33075, France

Location

CHU Trousseau

Chambray-lès-Tours, 37171, France

Location

Hôpital Beaujon

Clichy, 92118, France

Location

CHU Michallon

Grenoble, 38043, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU Timone

Marseille, 13385, France

Location

Hôpital Archet 2

Nice, 06202, France

Location

Hôpital du Haut Leveque

Pessac, 33604, France

Location

Hôpital Robert Debré

Reims, 51092, France

Location

CHU St Etienne

Saint-Priest, 42270, France

Location

Hôpital Rangueil

Toulouse, 31059, France

Location

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Semmelweis University

Budapest, 1088, Hungary

Location

Karádi-Nagy Bt.

Pécs, 7624, Hungary

Location

Hadasit Medical Research

Jerusalem, Israel

Location

Ospedale Regina Apostolorum

Albano Laziale, Italy

Location

Ospedale Pesenti Fenaroli

Alzano Lombardo, Italy

Location

Ospedale Civile

Castelfranco Veneto, Italy

Location

Università degli Studi di Chieti

Chieti, Italy

Location

Istituti Ospedalieri di Cremona

Cremona, Italy

Location

Azienda Ospedaliera-Universitaria Policlinico

Modena, Italy

Location

U.O.C. Malattie dell'Apparato Digerente e del Fegato

Roma, Italy

Location

Unità di Endocrinologia Istituti Fisioterapici Ospitalieri

Roma, Italy

Location

Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

Istituto Oncologico del Mediterraneo

Viagrande, Italy

Location

Szpital Uniwersytecki im. A. Jurasza

Bydgoszcz, Poland

Location

Slaskiego Uniwersytetu Medycznego

Katowice, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Szpital Uniwersytecki w Lodzi

Lodz, Poland

Location

Prywatna Praktyka Lekarska

Olsztyn, Poland

Location

Specjalistyczny Gabinet Lekarski

Poznan, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Szczecin, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej

Warsaw, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

Warsaw, Poland

Location

Wojskowy Instytut Medyczny

Warsaw, Poland

Location

Hospital Clinico Universitario de Santiago

A Coruña, Spain

Location

Hospital De Cruces

Barakaldo, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

Hospital General Reina Sofia

Córdoba, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Xeral Cies de Vigo

Pontevedra, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

University Hospital of Wales

Cardiff, CF14 4XN, United Kingdom

Location

University Hospital

Coventry, CV2 2DX, United Kingdom

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Chrisite Hospital Institute

Manchester, M204BX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

  • Ruszniewski P, Valle JW, Lombard-Bohas C, Cuthbertson DJ, Perros P, Holubec L, Delle Fave G, Smith D, Niccoli P, Maisonobe P, Atlan P, Caplin ME; SYMNET study group. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study. Dig Liver Dis. 2016 May;48(5):552-558. doi: 10.1016/j.dld.2015.12.013. Epub 2016 Jan 15.

MeSH Terms

Conditions

Neuroendocrine TumorsSerotonin Syndrome

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

  • Ipsen Study Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

November 4, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations