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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01234168
First received: October 20, 2010
Last updated: January 31, 2013
Last verified: January 2013
History of Changes

October 20, 2010
January 31, 2013
October 2010
December 2012   (final data collection date for primary outcome measure)
Subject's overall satisfaction regarding control of diarrhea [ Time Frame: Day of survey ] [ Designated as safety issue: No ]
Use of questionnaires to assess patient satisfaction (Likert scale).
Same as current
Complete list of historical versions of study NCT01234168 on ClinicalTrials.gov Archive Site
Impact on daily activities of the clinical manifestations of diarrhea [ Time Frame: Day of survey ] [ Designated as safety issue: No ]
Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S).
Same as current
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A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea
An International, Cross Sectional, Non-interventional, Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

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.
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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Out-patients
Neuroendocrine Tumour (NET) With Carcinoid Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
December 2012
December 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   France,   Hungary,   Israel,   Italy,   Poland,   Spain,   United Kingdom
 
NCT01234168
8-79-52030-736
No
Ipsen
Ipsen
Not Provided
Study Director: Christine Massien, MD Ipsen
Ipsen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP