Non Interventional Post Marketing Programme in Neuroendocrine Tumours

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. Identifier: NCT00747786
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : October 8, 2013
Information provided by (Responsible Party):

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
Neuroendocrine Tumors

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 : December 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. efficacy of Somatuline Autogel [ Time Frame: End of observational period ]
  2. training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ]
  3. acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with neuroendocrine tumours seen in routine clinic

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).

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 identifier (NCT number): NCT00747786

United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Royal Free Hospital
London, United Kingdom
St. Bartholomew's Hospital
London, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Study Director: Anne Fairey, MD Ipsen

Responsible Party: Ipsen Identifier: NCT00747786     History of Changes
Other Study ID Numbers: Y-97-52030-215
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue