E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptoms associated with carcinoid syndrome in patients with neuroendocrine tumours |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007270 |
E.1.2 | Term | Carcinoid syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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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E.2.2 | Secondary objectives of the trial |
To compare the two treatment administration groups with respect to: -Health Economy -Efficacy (symptom & biochemical control) -Safety -The healthcare provider´s experience of the patient’s lanreotide Autogel administration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Provision of written informed consent. Provision of written informed consent by the patient’s partner if he/she will be administering the Somatuline Autogel injections during the self administration block., (2) Male or female aged 18 years of age or older, (3) Treated with Somatuline Autogel 90 mg or120mg 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, (4) Neuroendocrine tumour confirmed by biopsy and visible on radiology, (5) Ability to store the study medication in a refrigerator at home.
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E.4 | Principal exclusion criteria |
The presence of any of the following will exclude a patient from inclusion in the study: (1) Has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure, (2) Has been treated with any other investigational medicinal product (IMP) within the last 3 months before study entry, (3) Has a risk of pregnancy or performing lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier or injectable contraception. (Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study), (4) Has a history of, or known current, problems with substance or alcohol abuse, (5) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, (6) 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, (7) Has a life expectancy less than a year, as judged by the Investigator, (8) The patient or their partner is not considered competent in injection technique, as judged by the Investigator, (9) The patient has previously entered this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients preferring self/partner administration healthcare professional administration at the last visit. A global question will be used. The question will be answered and recorded in the diary card by the patient. The following question will be answered: “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 Please give main reason:_____________________________________
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Administration by health care professional vs self/partner administration |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |