Non Interventional Post Marketing Programme in Neuroendocrine Tumours

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00747786

Enrollment

Registered

2008-09-05

Start date

2008-12-31

Completion date

2013-08-31

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional	End of observational period

Secondary

Measure	Time frame
efficacy of Somatuline Autogel	End of observational period
training requirements for patients / partners to perform home injection of Somatuline Autogel	End of observational period
acceptability of home injections to patients, partners and healthcare professionals	End of observational period

Countries

United Kingdom

Outcome results