Current partner codePEPTIDESDE
NCT01234168·Not applicable·OBSERVATIONAL

A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

Status

Completed

Phase

Not applicable

Enrollment

340

Locations

57

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Nov 4, 2010

  2. Study start

    Oct 2010

  3. Primary completion

    Dec 2012

  4. Study completion

    Dec 2012

  5. Results posted

    Not reported

  6. Registry updated

    Nov 5, 2020

Outcomes

What the study measures.

Primary outcomes

Subject's overall satisfaction regarding control of diarrhea

Time frame · Day of survey

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

Secondary outcomes

Impact on daily activities of the clinical manifestations of diarrhea

Time frame · Day of survey

Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

57 registered sites.

Czechia · France · Hungary · Israel · Italy · Poland · Spain · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Teaching Hospital Brno Bohunice

Brno, Czechia

University Hospital Hradec Kralove

Hradec Králové, Czechia

Hospital Pardubice

Pardubice, Czechia

Teaching Hospital

Pilsen, Czechia

Charles University

Prague, Czechia

Teaching Hospital Na Bulovce

Prague, Czechia

CHU Angers

Angers, France

Hôpital Avicenne

Bobigny, France

Hôpital Saint André

Bordeaux, France

CHU Trousseau

Chambray-lès-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, France

Semmelweis University

Budapest, Hungary

Karádi-Nagy Bt.

Pécs, Hungary

Hadasit Medical Research

Jerusalem, Israel

Ospedale Regina Apostolorum

Albano Laziale, Italy

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