E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
excessive production of growth hormone which causes a progressive deformation of the face, hands and feet |
esagerata produzione dell’ormone della crescita che provoca una deformazione progressiva del volto, delle mani e dei piedi |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000599 |
E.1.2 | Term | Acromegaly |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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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 |
confirm efficacy and safety of treatment with lanreoride at doses increased and reduced time intervals between doses in patients with acromegaly poorly responsive to standard treatment |
confermare efficacia sicurezza del trattamento con lanreoride a dosi incrementati e ridotti intervalli di tempo tra le somministrazioni in pazienti affetti da acromegalia scarsamente responsivi al trattamento standard |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age> = 18 years
Basal GH> = 1 microg / l,
IGF1> 1.2 x ULN (age and sex)
Ongoing treatment with lanreotide 120 mg every 4 weeks or octreotide 30 mg every 4 weeks for at least 6 months prior to randomization
Reduction of GH> = 50% in the course of therapy with LLSSA to standard doses compared to pretreatment values
Written informed consent |
Età >=18 anni
GH basale >= 1 microg/l,
IGF1 > 1,2 x ULN (per età e sesso)
Trattamento in corso con lanreotide 120 mg ogni 4 settimane o octreotide 30 mg ogni 4 settimane da almeno 6 mesi prima della randomizzazione
Riduzione di GH >= 50% in corso di terapia con LLSSA a dosi standard rispetto ai valori di pretrattamento
Consenso informato scritto |
|
E.4 | Principal exclusion criteria |
Symptomatic cholelithiasis
Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction in the 3 months prior to enrollment.
Liver disorders such as cirrhosis, chronic hepatitis, persistent rise in transaminase levels (AST, ALT, alkaline phosphatase 2 x ULN, total bilirubin 1.5 x ULN) or renal dysfunction (creatinine 1.5 x ULN) evaluated at screening;
Radiotherapy performed in the 5 years prior to enrollment and surgery for acromegaly performed in the 6 months prior to enrollment
Pregnant or breast-feeding women and women of childbearing age who do not adopt contraceptive methods. For women enrolled in the study, will require a negative urine pregnancy test at enrollment
Concomitant treatment with drugs able to modify the secretion of GH or IGF-1, as eg. dopamine agonists and pegvisomant
History of hypersensitivity to treatment with lanreotide
At the time of screening, and / or enrollment, adverse events being considered related to treatment with SSA of severity greater than grade 1. |
Colelitiasi sintomatica
Angina instabile, tachicardia ventricolare sostenuta, fibrillazione ventricolare o una storia di infarto miocardico acuto nei 3 mesi precedenti l’arruolamento.
Disfunzioni epatiche quali cirrosi, epatite cronica, persistente rialzo dei livelli di transaminasi (AST, ALT, fosfatasi alcalina 2 x ULN, bilirubina totale 1.5 x ULN); o disfunzioni renali (creatinina 1.5 x ULN) valutati allo screening;
Radioterapia effettuata nei 5 anni precedenti l’arruolamento e chirurgia per acromegalia effettuata nei 6 mesi precedenti l’arruolamento
Stato di gravidanza o allattamento; donne e uomini in età fertile che non adottano metodi contraccettivi. Per le donne arruolate nello studio, sarà richiesto un test di gravidanza sulle urine negativo all’arruolamento
Trattamento concomitante con farmaci in grado di modificare la secrezione di GH o IGF1, come ad es. agonisti della dopamina e pegvisomant
Storia di ipersensibilità al trattamento con lanreotide
Al momento dello screening, e/o dell’arruolamento, eventi avversi in corso considerati legati al trattamento con SSA di severità superiore al grado 1.
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E.5 End points |
E.5.1 | Primary end point(s) |
Biochemical control of acromegaly (IGF-I ≤ 1.2 x ULN and basal GH <1 mg / L) |
Controllo biochimico dell’acromegalia (IGF-I ≤ 1.2 x ULN e GH basale < 1 µg/L) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 24 weeks of treatment |
Dopo trattamento di 24 settimane |
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E.5.2 | Secondary end point(s) |
Number of serious and not serious adverse events |
Numero di eventi avversi seri e non seri |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
For the entire duration of the study |
Per tutta la durata dello studio |
|
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 | Yes |
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 | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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STUDY DURATION 19 MONTHS |
DURATA DELLO STUDIO 19 MESI |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 19 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 19 |
E.8.9.2 | In all countries concerned by the trial days | 0 |