Comparison of the efficacy of levothyroxine preparations in tablet form and liquid form (drops)

Phase 1

• Conditions: Hypothyroidism in children.; MedDRA version: 18.1Level: PTClassification code 10021114Term: HypothyroidismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-002462-24-GR
• Lead Sponsor: I-PHARMA SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-13
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified