Somatuline Autogel Preference and Health Economy Study
SAPHE
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.
2 other identifiers
interventional
26
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2008
Typical duration for phase_4
10 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
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
March 13, 2012
CompletedNovember 22, 2019
November 1, 2019
2.2 years
May 19, 2008
September 1, 2011
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Subject Preference for Self or Partner Administration
A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection
Between week 30 to 34
Secondary Outcomes (9)
Number of Patients Stating at Least One Injection Interfered With Daily Activities
Between baseline to week 32, after each injection (8-9 injections)
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
Between baseline to week 32, after each injection (8-9 injections)
Days Sick Leave
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)
Total Number of Visits to HCP Due to Carcinoid Symptoms
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)
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
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).
- +4 more secondary outcomes
Interventions
90 mg or 120 mg once every 28th day
Eligibility Criteria
You may qualify if:
- 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
- Neuroendocrine tumour confirmed by biopsy and visible on radiology
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (10)
Aarhus University Hospital / Medisinsk afd. V
Aarhus, 8000, Denmark
Odense Univeristy Hospital / S-AMB
Odense, 5000, Denmark
Haukeland University Hospital / Kreftafd
Bergen, 5021, Norway
University Hospital North-Norway / GastroLab
Tromsø, 9038, Norway
S:t Olavs Hospital / Medisinsk Afd
Trondheim, 7006, Norway
Sahlgrenska University Hospital / Kirurgkliniken
Gothenburg, 413 45, Sweden
Linköping University Hospital / Onkologen
Linköping, 581 85, Sweden
Karolinska University Hospital, Huddinge / GastroCentrum Medicin
Stockholm, 141 86, Sweden
Karolinska University Hospital, Solna / Kirurgmottagningen
Stockholm, 171 76, Sweden
Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Uppsala, 752 85, Sweden
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Director, Endocrinology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
June 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
November 22, 2019
Results First Posted
March 13, 2012
Record last verified: 2019-11