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
1 other identifier
observational
40
1 country
5
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2008
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 5, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJanuary 7, 2019
January 1, 2019
4.3 years
September 4, 2008
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
End of observational period
Secondary Outcomes (3)
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
Eligibility Criteria
Patients with neuroendocrine tumours seen in routine clinic
You may qualify if:
- 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.
You may not qualify if:
- The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (5)
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, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 5, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2013
Study Completion
August 1, 2013
Last Updated
January 7, 2019
Record last verified: 2019-01