E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected with moderately severe and severe GO |
Pazienti affetti da GO moderatamente severa e severa |
|
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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10015919 |
E.1.2 | Term | Eye disorders |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10043739 |
E.1.2 | Term | Thyroid gland disorders |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
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 evaluate the overall outcome of GO in terms of improvement, worsening or stability, following radioiodine ablation of post-surgical thyroid remnants, in patients with moderately severe and severe GO, at the end of the follow up period (12 months) |
Valutare l'andamento complessivo della GO in termini di miglioramento, peggioramento, stabilita' dopo ablazione del residuo tiroideo post-chirurgico in pazienti con GO moderatamente severa e severa, dopo follow up di 12 mesi |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the effects of acute rhTSH administration in GO; 2. To evaluate the overall outcome of GO at 45 days, 3 and 6 months following thyroidectomy/total thyroid ablation; 3. To evaluate changes in the quality of life during and at the end of the follow up period (3, 6 and 12 months) |
1. Valutare gli effetti della somministrazione in acuto di rhTSH sulla GO; 2. Valutare l'andamento della GO a 45 giorni, 3 e 6 mesi dopo la tiroidectomia totale + ablazione radiometabolica del residuo tiroideo post-chirurgico dopo stimolo con rhTSH; 3. Valutare i cambiamenti in termini di qualita' della vita dei pazienti a 3,6 e 12 mesi |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Hyperthyroidism onset<6 months treated only with anti-thyroid drugs; 2. GO onset <6 months; 3. Thyroid surgery indication (thyroid volume >15 ml and/or nodular goiter and/or hyperthyroidism relapse during despite anti-thyroid drugs and/or poor compliance to the medical treatment); 4. Moderately severe and severe GO; 5. Clinically active GO (Clinical Activity Score >3/7 |
1. Inizio dell'ipertiroidismo trattato solo con anti-tiroidei <6 mesi; 2. Esordio della GO <6 mesi; 3. Indicazioni alla chirurgia tiroidea (volume tiroideo >15 ml e/o gozzo nodulare e/o recidiva dell'ipertiroidismo durante e a dispetto della terapia antitiroidea e/o scarsa risposta al trattamento medico; 4. GO moderatamente severa e severa; 5. Go clinicamente attiva (Clinical Activity Score >3/7 |
|
E.4 | Principal exclusion criteria |
1. Hyperthyroidism onset >6 months or previously treated by radioiodine or thyroidectomy; 2. GO onset >6 months; 3. Mild GO; 4. Previous GO treatment by glucocorticoids, orbital irradiation or decompressive surgery; 5. Urgent orbital decompressive surgery; 6. Histopathological evidence of thyroid malignancy; 7. Pregnancy or breast-feading |
1. Inizio dell'ipertiroidismo >6 mesi o precedentemente trattato con radioiodio o tiroidectomia; 2. Esordio della GO >6 mesi; 3. GO lieve; 4. GO precedentemente trattata con steroidi, irradiazione orbitaria o chirurgia decompressiva; 5. Decompressione orbitaria urgente; 6. Evidenza istologica di malignita' tiroidea; 7. Gravidanza o allattamento |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Improving moderately severe and severe GO outcome |
Migliorare l'andamento della GO moderatamente severa e severa |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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) | 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 | No |
E.8.1.3 | Single blind | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 12 |
E.8.9.1 | In the Member State concerned days | 0 |