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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors

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Trial Information

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


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).

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional

Outcome Time Frame:

End of observational period

Safety Issue:

Yes

Principal Investigator

Anne Fairey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

United Kingdom: National Health Service

Study ID:

Y-97-52030-215

NCT ID:

NCT00747786

Start Date:

December 2008

Completion Date:

August 2013

Related Keywords:

  • Neuroendocrine Tumors
  • Neuroendocrine Tumors

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