Somatuline Autogel Preference and Health Economy Study (SAPHE)

Ipsen

Status and phase

Completed

Phase 4

Conditions

Neuroendocrine Tumour With Carcinoid Symptoms

Treatments

Drug: lanreotide (Autogel formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00681187

2007-006514-42 (EudraCT Number)

A-99-52030-216

Details and patient eligibility

About

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 administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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