Neuroendocrine Tumour With Carcinoid Symptoms Clinical Trial
— SAPHEOfficial 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.
| Verified date | November 2019 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | August 2010 |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital / Medisinsk afd. V | Aarhus | |
| Denmark | Odense Univeristy Hospital / S-AMB | Odense | |
| Norway | Haukeland University Hospital / Kreftafd | Bergen | |
| Norway | University Hospital North-Norway / GastroLab | Tromsø | |
| Norway | S:t Olavs Hospital / Medisinsk Afd | Trondheim | |
| Sweden | Sahlgrenska University Hospital / Kirurgkliniken | Gothenburg | |
| Sweden | Linköping University Hospital / Onkologen | Linköping | |
| Sweden | Karolinska University Hospital, Huddinge / GastroCentrum Medicin | Stockholm | |
| Sweden | Karolinska University Hospital, Solna / Kirurgmottagningen | Stockholm | |
| Sweden | Akademiska Hospital/ Kliniken f onkologisk endokrinologi | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
Denmark, Norway, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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?' | Between baseline to week 32, after each injection (8-9 injections) | |
| Secondary | 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?' | Between baseline to week 32, after each injection (8-9 injections) | |
| Secondary | 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). | 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) | |
| Secondary | 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. | 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) | |
| Secondary | 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. | 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). | |
| Secondary | 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. | 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). | |
| Secondary | 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. |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. | |
| Secondary | 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. |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. | |
| Secondary | 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? |
Between week 30 to 34 |