Hypothyroidism in children. MedDRA version: 18.1 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: T4 tablets, any strength
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVOTHYROXINE SODIUM
CAS Number: 55-03-8
Concentration unit: µg microgram(s)
Concentration type: range
Concentrati
Sponsors
UNI-PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written parental informed consent. 2. Patients of both genders. 3. Patients with similar age and parents with similar socio-economic level so as the level of understanding before the consent to be the same. 4. Age of 4-8 years old. 5. Patients with diagnosed congenital hypothyroidism. 6. Patients already on replacement therapy with T4® Tablets. 7. TSH values 0.5-5 µU/mL. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age less than 4 years, or more than 8 years. 2. Absence of a written consent from parents. 3. New patients not already receiving replacement therapy. 4. Patients not controlled regarding thyroid hormones. 5. TSH values off limits 0.5-5 µU / mL. 6. Patients receiving as replacement therapy a formulation other than T4® Tablets. 7. Insufficient compliance in patients already receiving replacement therapy, as evidenced by TSH values greater than 5 µU / mL. 8. Hyperthyroidism of any etiology. 9. Co-occurring cardiovascular diseases or other chronic diseases or syndromes. 10. Patients with adrenal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a new levothyroxine liquid formulation (T4® Oral drops, solution 100 ug / ml) versus the classic form (T4® Tablets) in infants and children who suffer from congenital hypothyroidism, during the study. The aim is to avoid a statistical difference between the results of hormonal measurements to the respective intervals between the two groups. ;Secondary Objective: • Measurement of the percentage of patients who had to increase or reduce the dose when changing from tablets to liquid form. • Comparison of the study groups regarding the patients who had to increase or reduce the dose during treatment. ;Primary end point(s): To compare during the study the efficacy of a new levothyroxine liquid formulation (T4® Oral drops, solution 100µg/ml) versus the classic form (T4® Tablets) in infants and children with congenital hypothyroidism.;Timepoint(s) of evaluation of this end point: 6 months from the inclusion of the last patient in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Measurement of the percentage of patients who had to increase or reduce the dose when changing from tablets to liquid form. • Comparison of the study groups regarding the patients who had to increase or reduce the dose during treatment. ;Timepoint(s) of evaluation of this end point: 6 months from the inclusion of the last patient in the study | — |
Countries
Greece
Contacts
Public ContactRegulatory Affairs department
Uni-Pharma SA
Outcome results
None listed