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

Completed

• Conditions: Neuroendocrine Tumors; Carcinoid Syndrome

• Registration Number: NCT01234168
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject's overall satisfaction regarding control of diarrhea	Day of survey	Use of questionnaires to assess patient satisfaction (Likert scale).

Secondary Outcome Measures

Name	Time	Method
Impact on daily activities of the clinical manifestations of diarrhea	Day of survey	Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S).

Trial Locations

Locations (57)

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, Czechia

CHU Angers; 🇫🇷 Angers, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

Hôpital Saint André; 🇫🇷 Bordeaux, France

CHU Trousseau; 🇫🇷 Chambray Les Tours, France

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