E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients thyroidectomized for differentiated thyroid cancer |
pazienti tiroidectomizzati per carcinoma tiroideo differenziato |
|
E.1.1.1 | Medical condition in easily understood language |
patients thyroidectomized for differentiated thyroid cancer |
pazienti tiroidectomizzati per carcinoma tiroideo differenziato |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057242 |
E.1.2 | Term | Post surgical hypothyroidism |
E.1.2 | System Organ Class | 100000004863 |
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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 compare the variation of free thyroxine circulating levels after oral administration of levo-thyroxine in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration |
Confrontare le variazioni delle concentrazioni ematiche di FT4 successive alla somministrazione orale di Levo-tiroxina in pazienti tiroidectomizzati per carcinoma tiroideo differenziato, con e senza RAIT, dopo 1 mese dalla prima somministrazione di 200 mcg di levo-tiroxina. |
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E.2.2 | Secondary objectives of the trial |
To evaluate changes in free thyroxine circulating levels after oral administration of levo-thyroxine in either solid or liquid preparations after 1 months, 3 and 6 months from the first 200mcg Levo-thyroxine administration |
Misurare la variazione delle concentrazioni ematiche di FT4 successive alla somministrazione orale di Levo-tiroxina in forma solida vs. liquida, dopo 1 mese, 3 mesi e 6 mesi dalla prima somministrazione di 200 mcg di levo-tiroxina. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Adult patients thyroidectomized for differentiated thyroid cancer
-Written informed consent to partecipate in the study |
-Pazienti adulti che abbiano eseguito tiroidectomia totale per carcinoma tiroideo differenziato
-Consenso informato scritto a partecipare allo studio. |
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E.4 | Principal exclusion criteria |
-Patients who will undergo radioactive iodine therapy in a hypothyroid state
-Inflammatory bowel diseases
-Malabsorption, chronic gastritis
-Treatment with estrogens, selective estrogen receptor modulators, drugs known to modify Levo-thyroxine absorption (i.e.: proton pump inhibitors, resins, iron, sucralfate, calcium, alluminum, chemotherapy, immunosuppressive therapy)
-Previous radiotherapy or radioactive iodine therapy
-Pregnancy
-Organ failure or other disease known to limit life expectancy
-History of chronic inflammatory/infectious/autoimmune diseases
-Any abnormality found during clinical examination at the screening visit, which according to the opinion of the investigator may be harmful for the patient in order to complete the study
-History of low compliance or psychiatric illness or any other condition which make the study inappropriate |
-Esecuzione di terapia radiometabolica ablativa previa induzione di ipotiroidismo da sospensione della terapia con Levo-tiroxina
-Malattie infiammatorie intestinali
-Malassorbimento, gastrite cronica
-Uso di estrogeni, SERM, farmaci in grado di determinare alterazioni dell’assorbimento di levo-tiroxina (inibitori di pompa protonica, resine, terapia marziale, sucralfato, calcio carbonato, idrossido di alluminio, chemioterapici o immunosoppressori)
-Pregressa radioterapia
-Gravidanza
-Insufficienza d’organo o altre patologie di rilievo che limitino l’aspettativa di vita;
-Storia di malattie croniche di tipo infiammatorio/infettivo/autoimmune;
-Qualsiasi anomalia clinicamente significativa riscontrata durante la valutazione di esame obiettivo o segni vitali alla visita di screening che a giudizio dello sperimentatore possa precludere la sicurezza del paziente durante tutta la durata dello studio;
-Storia di ridotta compliance o patologia psichiatrica rilevante o qualsiasi altra condizione che renda il paziente inappropriato per lo studio
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E.5 End points |
E.5.1 | Primary end point(s) |
Variation of free thyroxine circulating levels after oral administration of levo-thyroxine, evaluated as area under the curve (AUC), in patients thyroidectomized for differentiated thyroid cancer, with and without radioactive iodine therapy, after 1 months from the first 200mcg Levo-thyroxine administration |
Variazioni delle concentrazioni ematiche di FT4 successive alla somministrazione orale di Levo-tiroxina in pazienti tiroidectomizzati per carcinoma tiroideo, espresse come area sotto la curva (AUC), in pazienti con e senza RAIT, dopo 1 mese dalla prima somministrazione di 200 mcg di levo-tiroxina. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
variation of free thyroxine circulating levels after oral administration of levo-thyroxine, evaluated as area under the curve (AUC), in patients thyroidectomized for differentiated thyroid cancer, after 1 months, 3 and 6 months from the first 200mcg Levo-thyroxine administration |
Variazione delle concentrazioni ematiche di FT4 successive alla somministrazione orale di Levo-tiroxina tra forma solida e forma liquida, espresse come area sotto la curva (AUC), in pazienti tiroidectomizzati per carcinoma tiroideo dopo 1 mese, 3 mesi e 6 mesi dalla prima somministrazione di 200 mcg di levo-tiroxina. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stesso principio attivo ma forma farmaceutica differente |
same active substance but different farmaceutical form |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |