Non Interventional Post Marketing Programme in Neuroendocrine Tumours

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00747786
First received: September 4, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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
Neuroendocrine Tumors

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficacy of Somatuline Autogel [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
  • training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
  • acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: August 2013
Primary Completion Date: April 2013 (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

Patients with neuroendocrine tumours seen in routine clinic

Criteria

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
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: NCT00747786

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

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00747786     History of Changes
Other Study ID Numbers: Y-97-52030-215
Study First Received: September 4, 2008
Last Updated: October 7, 2013
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on August 18, 2014