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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006514-42 | EudraCT Number |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | 90 mg or 120 mg once every 28th day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital / Medisinsk afd. V | Aarhus | 8000 | Denmark | |||
| Odense Univeristy Hospital / S-AMB |
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Data from ninety-four subjects was reviewed in hospital clinics in Denmark, Norway and Sweden. Of which 32 were ineligible, 36 were eligible but chose not to participate due to lack of motivation, satisfaction with current form of administration or fear of self-injection and 26 were included. Patients were recruited from Jun-08 to Jan-10.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Self or Partner First Then HCP Administration | Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (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 subject's home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day. |
| FG001 | Group 2 HCP Then Self or Partner Administration | Started 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 subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject's home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Self or Partner First Then HCP Administration | Self or partner administration followed by HCP administration. |
| BG001 | Group 2 HCP Then Self or Partner Administration | Administration by HCP then self or partner administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded | Posted | Number | participants | Between week 30 to 34 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training Period | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Endocrinology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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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) |
| 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) |
| 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) |
| 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). |
| 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). |
| 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. |
| 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. |
| 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:
| Between week 30 to 34 |
| Odense |
| 5000 |
| Denmark |
| Haukeland University Hospital / Kreftafd | Bergen | 5021 | Norway |
| University Hospital North-Norway / GastroLab | Tromsø | 9038 | Norway |
| S:t Olavs Hospital / Medisinsk Afd | Trondheim | 7006 | Norway |
| Sahlgrenska University Hospital / Kirurgkliniken | Gothenburg | 413 45 | Sweden |
| Linköping University Hospital / Onkologen | Linköping | 581 85 | Sweden |
| Karolinska University Hospital, Huddinge / GastroCentrum Medicin | Stockholm | 141 86 | Sweden |
| Karolinska University Hospital, Solna / Kirurgmottagningen | Stockholm | 171 76 | Sweden |
| Akademiska Hospital/ Kliniken f onkologisk endokrinologi | Uppsala | 752 85 | Sweden |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Administration by HCP then Self or Partner Administration.
|
|
| 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?' | Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded | Posted | Number | Participants | 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?' | Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded | Posted | Number | participants | Between baseline to week 32, after each injection (8-9 injections) |
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|
|
| 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). | Safety population: all randomised 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. | Posted | Number | days | 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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|
|
| 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. | Safety population: all randomised subjects with at least one dose of study medication | Posted | Number | visits | 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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|
|
| 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. | Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded. | Posted | Number | participants | 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. | Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded. | Posted | Number | participants | 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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| 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. | ITT population that had hormone levels assessed at each administration block. | Posted | Mean | Standard Deviation | nmol/l | Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. |
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|
|
| 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. | 5-HIAA were assessed as judged necessary by the investigator at each site. | Posted | Mean | Standard Deviation | nmol/l | Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. |
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| 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:
| One HCP from each site who enrolled participants replied to the question | Posted | Number | participants | Between week 30 to 34 |
|
|
|
| 4 |
| 26 |
| 7 |
| 26 |
| EG001 | Self or Partner Administration | The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home. | 4 | 26 | 4 | 26 |
| EG002 | HCP Administration | A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility. | 3 | 26 | 7 | 26 |
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Biliary tract infection | Infections and infestations | Non-systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | Non-systematic Assessment |
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| Death | General disorders | Non-systematic Assessment |
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| Disease progression | General disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Peritoneal cyst | Gastrointestinal disorders | Non-systematic Assessment |
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| Post procedural fistula | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Subileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Flushing | Vascular disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Injection site pain | General disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Improved |
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| Missing |
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| Title | Measurements |
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| Improved |
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| Missing |
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