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
  Purpose

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.


Condition
Neuroendocrine Tumour (NET) With Carcinoid Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 340
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Out-patients

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234168

  Show 57 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Christine Massien, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01234168     History of Changes
Other Study ID Numbers: 8-79-52030-736
Study First Received: October 20, 2010
Last Updated: January 31, 2013
Health Authority: United Kingdom: National Health Service
France: French Data Protection Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Czech Republic: State Institute for Drug Control
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Ethics Commission

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Diarrhea
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Signs and Symptoms, Digestive
Signs and Symptoms
Drug Toxicity
Poisoning
Substance-Related Disorders
Lanreotide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014