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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:
ClinicalTrials.gov Identifier:
NCT01234168
First Posted: November 4, 2010
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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 Tumors 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234168


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01234168     History of Changes
Other Study ID Numbers: 8-79-52030-736
First Submitted: October 20, 2010
First Posted: November 4, 2010
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Syndrome
Diarrhea
Neuroendocrine Tumors
Carcinoid Tumor
Malignant Carcinoid Syndrome
Serotonin Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Lanreotide
Angiopeptin
Antineoplastic Agents


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