Neuroendocrine Tumour With Carcinoid SymptomsPhase 4SAPHENCT00681187
Somatuline Autogel Preference and Health Economy Study
A Phase 4 study testing lanreotide (Autogel formulation) in people with Neuroendocrine Tumour With Carcinoid Symptoms, run by Ipsen at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumour With Carcinoid Symptoms
- What is being tested?
- lanreotide (Autogel formulation)
- How many people
- 26 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jun 2008to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Sweden5 sites
Sahlgrenska University Hospital / Kirurgkliniken
Gothenburg, 413 45
Linköping University Hospital / Onkologen
Linköping, 581 85
Karolinska University Hospital, Huddinge / GastroCentrum Medicin
Stockholm, 141 86
Karolinska University Hospital, Solna / Kirurgmottagningen
Stockholm, 171 76
Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Uppsala, 752 85
Norway3 sites
Haukeland University Hospital / Kreftafd
Bergen, 5021
University Hospital North-Norway / GastroLab
Tromsø, 9038
S:t Olavs Hospital / Medisinsk Afd
Trondheim, 7006
Denmark2 sites
Aarhus University Hospital / Medisinsk afd. V
Aarhus, 8000
Odense Univeristy Hospital / S-AMB
Odense, 5000
About this 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.
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.
- Being tested
- lanreotide (Autogel formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanreotide (Autogel formulation)Drug
90 mg or 120 mg once every 28th day
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between week 30 to 34
Secondary outcomes (9)
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?'
Measured: Between baseline to week 32, after each injection (8-9 injections)
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?'
Measured: Between baseline to week 32, after each injection (8-9 injections)
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
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.
Measured: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
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?
Measured: Between week 30 to 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroendocrine Tumour With Carcinoid SymptomsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681187
- Sponsor's protocol ID
- A-99-52030-216
- Other IDs
- 2007-006514-42
- Acronym
- SAPHE
- Status last verified
- Nov 2019
- First submitted
- 19 May 2008
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00681187
- Acronym / sponsor ID
- SAPHE / A-99-52030-216
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanreotide (Autogel formulation)90 mg or 120 mg once every 28th day | Drug | – |
Primary outcome
Subject Preference for Self or Partner Administration
Time frame: Between week 30 to 34
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
9 secondary outcomes
Number of Patients Stating at Least One Injection Interfered With Daily Activities
Time frame: Between baseline to week 32, after each injection (8-9 injections)
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
Time frame: Between baseline to week 32, after each injection (8-9 injections)
Days Sick Leave
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)
Total Number of Visits 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)
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
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).
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
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).
Chromogranin A Levels
Time frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
5-hydroxyindoleacetic Acid (5-HIAA) Levels
Time frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Time frame: Between week 30 to 34
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lanreotide (Autogel formulation) in people with Neuroendocrine Tumour With Carcinoid Symptoms, run by Ipsen at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, Norway, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Preference for Self or Partner Administration (time frame: Between week 30 to 34). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.