Status:
COMPLETED
Non Interventional Post Marketing Programme in Neuroendocrine Tumours
Lead Sponsor:
Ipsen
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
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 sa...
Eligibility Criteria
Inclusion
- 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
- The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00747786
Start Date
December 1 2008
End Date
August 1 2013
Last Update
January 7 2019
Active Locations (5)
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1
University Hospital of Wales
Cardiff, United Kingdom
2
Aintree University Hospital
Liverpool, United Kingdom
3
Royal Free Hospital
London, United Kingdom
4
St. Bartholomew's Hospital
London, United Kingdom