Non Interventional Post Marketing Programme in Neuroendocrine Tumours

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747786
• Other study ID #: Y-97-52030-215
• Status: Completed
• Start date: December 2008
• Est. completion date: August 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional		End of observational period
Secondary	efficacy of Somatuline Autogel		End of observational period
Secondary	training requirements for patients / partners to perform home injection of Somatuline Autogel		End of observational period
Secondary	acceptability of home injections to patients, partners and healthcare professionals		End of observational period