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Non Interventional Post Marketing Programme in Neuroendocrine Tumours

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00747786
Collaborator
(none)
40
Enrollment
5
Locations
56
Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-Term Safety and Efficacy of Somatuline Autogel in the Treatment of Neuroendocrine Tumours When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals
    Study Start Date :
    Dec 1, 2008
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Aug 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional [End of observational period]

    Secondary Outcome Measures

    1. efficacy of Somatuline Autogel [End of observational period]

    2. training requirements for patients / partners to perform home injection of Somatuline Autogel [End of observational period]

    3. acceptability of home injections to patients, partners and healthcare professionals [End of observational period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this Post Marketing Surveillance programme and any subsequent analysis.

    • The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.

    • The patient must have a diagnosis of neuroendocrine tumours

    • The patient must be at least 18 years of age

    • For patients receiving or intending to receive Somatuline Autogel by home injection:

    • The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service.

    Exclusion Criteria:
    • The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Wales Cardiff United Kingdom
    2 Aintree University Hospital Liverpool United Kingdom
    3 Royal Free Hospital London United Kingdom
    4 St. Bartholomew's Hospital London United Kingdom
    5 Royal Hallamshire Hospital Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT00747786
    Other Study ID Numbers:
    • Y-97-52030-215
    First Posted:
    Sep 5, 2008
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Additional relevant MeSH terms:
    Neuroendocrine Tumors

    Study Results

    No Results Posted as of Jan 7, 2019