Clinical Trial Results:
A PHASE IV, 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
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Summary
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EudraCT number |
2007-006514-42 |
Trial protocol |
SE DK |
Global end of trial date |
16 Aug 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Mar 2016
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First version publication date |
11 Mar 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
A-99-52030-216
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ipsen AB
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Sponsor organisation address |
Kista Science Tower, Farogatan 33,, Kista, Sweden, 164 51
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Public contact |
Medical Director, Endocrinology, Ipsen, clinical.trials@ipsen.com
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Scientific contact |
Medical Director, Endocrinology, Ipsen, clinical.trials@ipsen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jul 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Aug 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Aug 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the patient preference of two lanreotide Autogel administration practices; self/partner or healthcare professional administration.
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Protection of trial subjects |
This clinical study was designed and implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Jun 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Norway: 4
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Country: Number of subjects enrolled |
Sweden: 15
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Country: Number of subjects enrolled |
Denmark: 7
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Worldwide total number of subjects |
26
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EEA total number of subjects |
26
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
14
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 94 patients were entered on the screening and recruitment logs of all 10 participating sites. Date of first enrolment: 13 June 2008. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
Out of 94 patients, 62 patients were offered participation. 32 were not eligible and 36 patients were chose not to participate mainly due to lack of motivation, satisfaction with current form of administration or fear of self-injection. 26 patients at nine sites entered the study of which 23 completed the study and 3 withdrew prematurely. | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sequence Group 1 (Self-HCP): lanreotide Autogel | |||||||||||||||||||||
Arm description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
lanreotide Autogel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
The study drug administered was lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection either in the upper external quadrant of the buttock or in the upper outer thigh.
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Arm title
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Sequence Group 2 (HCP-Self): lanreotide Autogel | |||||||||||||||||||||
Arm description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
lanreotide Autogel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
The study drug administered was lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection either in the upper external quadrant of the buttock or in the upper outer thigh.
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Baseline characteristics reporting groups
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Reporting group title |
Sequence Group 1 (Self-HCP): lanreotide Autogel
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Reporting group description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sequence Group 2 (HCP-Self): lanreotide Autogel
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Reporting group description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sequence Group 1 (Self-HCP): lanreotide Autogel
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Reporting group description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a training period where the patient or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The training injections were followed by a self-administration block of three subsequent unsupervised injections every 28th day at the patient’s home. | ||
Reporting group title |
Sequence Group 2 (HCP-Self): lanreotide Autogel
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Reporting group description |
lanreotide Autogel, 90 or 120 mg in a pre-filled syringe given as a deep subcutaneous injection. The study with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the patient or partner under supervision at the healthcare provider facilities. | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All randomised patients with at least one dose of study medication and with a preference assessment recorded.
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Subject analysis set title |
Baseline
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Baseline refers to the last non-study visit at the clinic.
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Subject analysis set title |
Group 1 Self or Partner First Then HCP Administration
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Self or Partner Administration followed by HCP Administration.
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Subject analysis set title |
Group 2 HCP Then Self or Partner Administration
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Administration by HCP then Self or Partner Administration.
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Subject analysis set title |
Training Period
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
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Subject analysis set title |
Self or Partner Administration
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
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Subject analysis set title |
HCP Administration
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
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End point title |
Subject Preference for Self or Partner Administration [1] | ||||||||||||
End point 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
Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
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End point type |
Primary
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End point timeframe |
Between week 30 to 34
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis provided for Subject Preference for Self or Partner Administration |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Patients Stating at Least One Injection Interfered With Daily Activities | ||||||||||||||||
End point description |
The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'.
Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
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End point type |
Secondary
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End point timeframe |
Between baseline to week 32, after each injection (8-9 injections).
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing | ||||||||||||||||
End point description |
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
-vely = Negatively, inj = Injection
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End point type |
Secondary
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End point timeframe |
Between baseline to week 32, after each injection (8-9 injections)
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Days Sick Leave | |||||||||
End point 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).
Safety population: all randomized subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.
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End point type |
Secondary
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End point timeframe |
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).
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| No statistical analyses for this end point | ||||||||||
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End point title |
Total Number of Visits to HCP Due to Carcinoid Symptoms | |||||||||
End point 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.
Safety population: all randomized subjects with at least one dose of study medication.
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End point type |
Secondary
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End point timeframe |
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).
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| No statistical analyses for this end point | ||||||||||
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End point title |
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing | ||||||||||||||||||||||||||||
End point 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.
Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
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End point type |
Secondary
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End point timeframe |
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).
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea | ||||||||||||||||||||||||||||
End point 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.
Analysis was performed on Intention to Treat population defined as all randomized subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
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End point type |
Secondary
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End point timeframe |
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).
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Chromogranin A Levels | ||||||||||||||||
End point description |
Biochemical control was assessed by analyzing 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.
ITT population that had hormone levels assessed at each administration block.
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End point type |
Secondary
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End point timeframe |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
5-hydroxyindoleacetic Acid (5-HIAA) Levels | ||||||||||||||||
End point 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.
5-HIAA were assessed as judged necessary by the investigator at each site.
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End point type |
Secondary
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End point timeframe |
Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method | ||||||||
End point 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?
One HCP from each site who enrolled participants replied to the question and the method used is Self or Partner Administration Method.
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End point type |
Secondary
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End point timeframe |
Between week 30 to 34.
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| No statistical analyses for this end point | |||||||||
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End point title |
Telephone Contacts with Study Site Staff | ||||||||||||
End point description |
Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the time, taken for telephone contacts with study site staff.
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End point type |
Secondary
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End point timeframe |
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).
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to visit 3
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Training Period
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Reporting group description |
The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Self or Partner Administration
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Reporting group description |
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
HCP Administration
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Reporting group description |
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Feb 2008 |
Local Danish Amendment: In Denmark, the following changes were made to the initial protocol following a request from the Ethics Committee in Region Midtjylland:
• A section to describe how the patients were recruited into the study was added.
• A section to describe potential risks and side effects were added.
• A section to describe the ethical aspects of the study was added.
• An appendix to define the financial situation was added, including details of who initiated the study, who the sponsor is, details of the financial agreement and information regarding the financial relationship between the Principal Investigator (PI) in Denmark and the sponsor.
• A section to clearly state that all results, whether positive or negative will be published was added.
• A more detailed section regarding the Informed Consent process was added. |
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13 Mar 2008 |
Amendment 1: In amendment 1, dated 13 March 2008, the following changes were made to the initial protocol:
• Patients with previous experience of self and/or partner-administered lanreotide Autogel should not be allowed to participate in the study due to the risk of receiving biased data.
• An inconsistency concerning the time between Visit 1 and 2 for Group 1 was corrected to 20-24 weeks throughout the protocol.
• The randomisation process was incorporated into the eCRF instead of being performed manually by the Clinical Study Coordinator at Ipsen. This change was made to minimise the risk of human randomisation errors, as well as to increase the availability.
• Patient initials were removed from the patient coding process. Only patient number was used as patient identification. Amendment 1 was submitted to all participating countries after initial approval. |
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12 Nov 2008 |
Amendment 2: In amendment 2, dated 12 November 2008, the following changes were made to the protocol:
• A misprint of the emergency phone number on the cover page was corrected.
• The recruitment period was extended by 6 months, from 6 to 12 months in order to reach the inclusion target.
• The maximum number of patients allowed per site was increased from 5 to 10 patients to allow high-recruiting sites to include more than 5 patients.
• The responsibility for data entry of laboratory values was transferred from study personnel to central laboratory personnel. Amendment 2 was submitted to Swedish and Norwegian regulatory authorities and Ethics Committees in Nov/Dec 2008. A modified version of amendment 2 was submitted to Danish regulatory authorities and Ethics Committees in April 2009 as local Danish amendment 2. |
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06 Apr 2009 |
Local Danish Amendment 2: In local Danish amendment 2, dated 06 April 2009, the following changes were made to the protocol:
• A misprint of the emergency phone number on the cover page was corrected.
• Recruitment period was extended by 12 months, from 6 to 18 months.
• Maximum number of patients allowed per site was increased from 5 to 10 patients.
• Compensation to high-recruiting sites was increased to compensate for time spent pre-screening patients.
Local Danish amendment 2 was submitted to Danish authorities as stated above. |
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29 Jan 2010 |
Amendment 3: The following changes were made to the protocol:
• The number of patients required for inclusion was reduced from 42 to 26 due to slow recruitment and a higher proportion of patients preferring self-partner administration compared to the value used in sample size calculations. Amendment 3 was submitted to regulatory authorities and ethics committees in all participating countries. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
