E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Unilateral recurrent laryngeal nerve palsy, after thyroidectomy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038130 |
E.1.2 | Term | Recurrent laryngeal nerve palsy |
E.1.2 | System Organ Class | 100000004852 |
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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 |
Study the effectiveness of oral corticosteroids in vocal fold remobilization (at Day 7) for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy |
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E.2.2 | Secondary objectives of the trial |
Study the incidence of unilateral recurrent laryngeal nerve palsy Study the rate of complete remobilization at M1 and M3 between placebo and corticosteroids group Study the rate of partial remobilization between at D7, M1 and M3 between placebo and corticosteroids group Observance and tolerance of oral corticosteroids
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients undergoing total or partial thyroidectomy (no lymphe node dissection) Age ≥ 18 yo Informed consent, and signed
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E.4 | Principal exclusion criteria |
Patients undergoing thyroid cancer surgery (with lymphe node dissection) Patients with pre operative recurrent laryngeal nerve palsy Patients with bilateral recurrent laryngeal nerve palsy Patients with allergy to Prednisolone Patients with ongoing infection
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete remobilization of laryngeal palsy, evaluated by naso fibroscope inspection at Day 7 after thyroidectomy Complete response is definied by optimal contact of paralysed vocal fold with controlateral vocal fold
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of recurrent laryngeal nerve palsy in studied population Complete remobilization of laryngeal palsy at M1 and M3 between placebo and corticosteroids group Partial remobilization of laryngeal palsy at D7, M1 and M3 between placebo and corticosteroids group (partial remobilization is definied by non optimal vocal fold movement) Observance and tolerance of oral corticosteroids evaluated by interrogation
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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 | Yes |
E.6.4 | Safety | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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
| 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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |