Clinical trial NCT00681187: Somatuline Autogel Preference and Health Economy Study
Official title: A Phase IV, International, Open-label, Randomised, Cross-over Study to Assess Patient Preference and Health Economy in Patients With Neuroendocrine Tumours, Treated With Lanreotide Autogel Given as Self Administration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuroendocrine Tumour With Carcinoid Symptoms
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Subject Preference for Self or Partner Administration
timeFrame: Between week 30 to 34
Secondary outcomes:
measure: Number of Patients Stating at Least One Injection Interfered With Daily Activities
timeFrame: Between baseline to week 32, after each injection (8-9 injections)
measure: Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
timeFrame: Between baseline to week 32, after each injection (8-9 injections)
measure: Days Sick Leave
timeFrame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
measure: Total Number of Visits to HCP Due to Carcinoid Symptoms
timeFrame: Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration)
measure: Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
timeFrame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).
measure: Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
timeFrame: Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).
measure: Chromogranin A Levels
timeFrame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
measure: 5-hydroxyindoleacetic Acid (5-HIAA) Levels
timeFrame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
measure: Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
timeFrame: Between week 30 to 34
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital / Medisinsk afd. V
city: Odense
country: Denmark
facility: Odense Univeristy Hospital / S-AMB
city: Bergen
country: Norway
facility: Haukeland University Hospital / Kreftafd
city: Tromsø
country: Norway
facility: University Hospital North-Norway / GastroLab
city: Trondheim
country: Norway
facility: S:t Olavs Hospital / Medisinsk Afd
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital / Kirurgkliniken
city: Linköping
country: Sweden
facility: Linköping University Hospital / Onkologen
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Huddinge / GastroCentrum Medicin
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna / Kirurgmottagningen
city: Uppsala
country: Sweden
facility: Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: