Back to resultsSomatuline Autogel Preference and Health Economy Study (SAPHE)
Primary Purpose
Neuroendocrine Tumour With Carcinoid Symptoms
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumour With Carcinoid Symptoms
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
Sites / Locations
- Aarhus University Hospital / Medisinsk afd. V
- Odense Univeristy Hospital / S-AMB
- Haukeland University Hospital / Kreftafd
- University Hospital North-Norway / GastroLab
- S:t Olavs Hospital / Medisinsk Afd
- Sahlgrenska University Hospital / Kirurgkliniken
- Linköping University Hospital / Onkologen
- Karolinska University Hospital, Huddinge / GastroCentrum Medicin
- Karolinska University Hospital, Solna / Kirurgmottagningen
- Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Patients Stating at Least One Injection Interfered With Daily Activities
The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
Days Sick Leave
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).
Total Number of Visits to HCP Due to Carcinoid Symptoms
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.
Chromogranin A Levels
Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.
5-hydroxyindoleacetic Acid (5-HIAA) Levels
Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Assessed by the number of HCP with a positive response 'yes' to two questions:
Based on your experience during this trial, did you feel confident in the safety of your patients?
Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681187
Brief Title
Somatuline Autogel Preference and Health Economy Study
Acronym
SAPHE
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumour With Carcinoid Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Intervention Description
90 mg or 120 mg once every 28th day
Primary Outcome Measure Information:
Title
Subject Preference for Self or Partner Administration
Description
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
Time Frame
Between week 30 to 34
Secondary Outcome Measure Information:
Title
Number of Patients Stating at Least One Injection Interfered With Daily Activities
Description
The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
Time Frame
Between baseline to week 32, after each injection (8-9 injections)
Title
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
Description
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
Time Frame
Between baseline to week 32, after each injection (8-9 injections)
Title
Days Sick Leave
Description
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).
Time Frame
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)
Title
Total Number of Visits to HCP Due to Carcinoid Symptoms
Description
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.
Time Frame
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)
Title
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Description
Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.
Time Frame
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).
Title
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Description
Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.
Time Frame
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).
Title
Chromogranin A Levels
Description
Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.
Time Frame
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Title
5-hydroxyindoleacetic Acid (5-HIAA) Levels
Description
Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.
'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.
'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.
'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.
'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.
Time Frame
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Title
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Description
Assessed by the number of HCP with a positive response 'yes' to two questions:
Based on your experience during this trial, did you feel confident in the safety of your patients?
Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?
Time Frame
Between week 30 to 34
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital / Medisinsk afd. V
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Odense Univeristy Hospital / S-AMB
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Haukeland University Hospital / Kreftafd
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
University Hospital North-Norway / GastroLab
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Facility Name
S:t Olavs Hospital / Medisinsk Afd
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Sahlgrenska University Hospital / Kirurgkliniken
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Linköping University Hospital / Onkologen
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Karolinska University Hospital, Huddinge / GastroCentrum Medicin
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Karolinska University Hospital, Solna / Kirurgmottagningen
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Akademiska Hospital/ Kliniken f onkologisk endokrinologi
City
Uppsala
ZIP/Postal Code
752 85
Country
Sweden
12. IPD Sharing Statement
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Somatuline Autogel Preference and Health Economy Study
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