Status:
COMPLETED
Somatuline Autogel Preference and Health Economy Study
Lead Sponsor:
Ipsen
Conditions:
Neuroendocrine Tumour With Carcinoid Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administr...
Eligibility Criteria
Inclusion
- Provision of written informed consent from the patient and their partner (if the partner will be administering the lanreotide Autogel injections during the self administration period)
- Male or female aged 18 years of age or older
- Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on a stable dose for at least 3 months prior to inclusion. The patient is presumed to be clinically stable during the coming months
- Neuroendocrine tumour confirmed by biopsy and visible on radiology
Exclusion
- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs with a similar chemical structure
- Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study
- Has a life expectancy less than a year, as judged by the Investigator
- The patient or their partner is not considered competent in injection technique, as judged by the Investigator
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00681187
Start Date
June 1 2008
End Date
August 1 2010
Last Update
November 22 2019
Active Locations (10)
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1
Aarhus University Hospital / Medisinsk afd. V
Aarhus, Denmark, 8000
2
Odense Univeristy Hospital / S-AMB
Odense, Denmark, 5000
3
Haukeland University Hospital / Kreftafd
Bergen, Norway, 5021
4
University Hospital North-Norway / GastroLab
Tromsø, Norway, 9038