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Non Interventional Post Marke...

Non Interventional Post Marketing Programme in Neuroendocrine Tumours

Last Updated: 2019-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2013-08-31

Brief Summary

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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").

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Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers