Primary outcomeNumber· Between week 30 to 34
Subject Preference for Self or Partner Administration
| Group | Value (participants) |
|---|---|
| Group 1 Self or Partner First Then HCP Administration | 10 |
| Group 2 HCP Then Self or Partner Administration | 12 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataSomatuline Autogel Preference and Health Economy Study
Short name SAPHE
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 26 participants (actual)
- Sponsor
- Ipsen · Industry
- Design
- Randomized · Open label (no masking)
- Countries
3 countries
Denmark, Norway, Sweden
- Start
- Jun 2008
- Primary completion
- Aug 2010
- Completion
- Aug 2010
- First posted
- 21 May 2008 (estimated)
- Last update posted
- 22 Nov 2019
- Conditions
- Neuroendocrine Tumour With Carcinoid Symptoms
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2008200920102011
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- lanreotide (Autogel formulation)Drug
Arms0
The registry lists no arms for this trial.
Primary outcomes1
Outcomes the sponsor listed as primary.
Subject Preference for Self or Partner Administration
Time frame · Between week 30 to 34
Registry 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
Secondary outcomes(9)
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)
Registry description
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
Time frame · Between baseline to week 32, after each injection (8-9 injections)
Registry description
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
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)
Registry 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).
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)
Registry 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.
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).
Registry 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.
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).
Registry 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.
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.
Registry 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.
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.
Registry 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.
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Time frame · Between week 30 to 34
Registry description
Assessed by the number of HCP with a positive response 'yes' to two questions: 1. Based on your experience during this trial, did you feel confident in the safety of your patients? 2. Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Between baseline to week 32, after each injection (8-9 injections)
Number of Patients Stating at Least One Injection Interfered With Daily Activities
| Group | Value (Participants) |
|---|---|
| Training Period | 6 |
| Self or Partner Administration | 2 |
| HCP Administration | 6 |
Secondary outcomeNumber· Between baseline to week 32, after each injection (8-9 injections)
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
| Group | Value (participants) |
|---|---|
| Training Period | 4 |
| Self or Partner Administration | 2 |
| HCP Administration | 1 |
Secondary outcomeNumber· 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)
Days Sick Leave
| Group | Value (days) |
|---|---|
| Self or Partner Administration | 23 |
| HCP Administration | 0 |
Secondary outcomeNumber· 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 | Value (visits) |
|---|---|
| Self or Partner Administration | 17 |
| HCP Administration | 25 |
Secondary outcomeNumber· 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 Flushing
| Group | Value (participants) |
|---|---|
| Baseline | 0 |
| Self or Partner Administration | 1 |
| HCP Administration | 1 |
Secondary outcomeNumber· 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).
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
| Group | Value (participants) |
|---|---|
| Baseline | 1 |
| Self or Partner Administration | 4 |
| HCP Administration | 0 |
Secondary outcomeMean· Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Chromogranin A Levels
| Group | Value (nmol/l) | Spread |
|---|---|---|
| Before Self or Partner Administration | 37.48 | 58.35 |
| After Self or Partner Administration | 47.85 | 74.89 |
| Before HCP Administration | 42.05 | 70.74 |
| After HCP Administration | 37.42 | 57.96 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Training PeriodThe training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. | – | 4 / 26 | 7 / 26 |
| Self or Partner AdministrationThe self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home. | – | 4 / 26 | 4 / 26 |
| HCP AdministrationA healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility. | – | 3 / 26 | 7 / 26 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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