Levothyroxine soft-gel efficacy with variation of intaking time in hypothyroidism replacement therapy

INTERVENTION: Trade Name: TICHE ‐ "88 MICROGRAMMI CAPSULE MOLLI" 100 CAPSULE IN BLISTER PVC‐PCTFE/AL Pharmaceutical Form: Capsule, soft INN or Proposed INN: 00179301 Current Sponsor code: . Other descriptive name: levothyroxine Concentration unit: µg microgram(s) Concentration type: range Concentration number: 75‐200 CONDITION: patients who underwent total thyroidectomy followed or not by ablative radioiodine therapy for differentiated thyroid carcinoma and then treated with levothyroxine replacement therapy, in disease remission ; MedDRA version: 20.0 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 ‐ Endocrine disorders Therapeutic area: Diseases [C] ‐ Hormonal diseases [C19] PRIMARY OUTCOME: Main Objective: to demonstrate the noninferiority between soft gel levothyroxine intake in the interval 0‐10 minutes with breakfast and its intake (for tablet formulation) 30 minutes before breakfast (at the same dosage used), for thyroid function replacement. Primary end point(s): Group sample sizes of 25 and 25 patients for each group achieve 91% power to detect non‐inferiority between soft gel levothyroxine intake in the interval 0‐10 minutes with breakfast and its intake (for tablet formulation) 30 minutes before breakfast (at the same dosage used), for thyroid function replacement. Non‐inferiority will be evaluated by comparing the levels of TSH measured in the control arm (in which patients will take levothyroxine in soft capsules 30 minutes before breakfast) and TSH levels measured in the experimental arm (in which patients will assume levothyroxine soft capsule in the range 0‐10 minutes with breakfast). Secondary Objective: to verify variation in quality of life related with variation of levothyroxine intaking time. Timepoint(s) of evaluation of this end point: 6 months SECONDARY OUTCOME: Secondary end point(s): there aren't secondary end points Timepoint(s) of evaluation of this end point: 0 INCLUSION CRITERIA: We will enroll adult subjects with primary hypothyroidism, able to express and sign an informed consent, in which replacement therapy has allowed to achieve the therapeutic target ( TSH between 0.8 and 1.6 mcU/ml). We will enroll patients who underwent total thyroidectomy followed or not by ablative radioiodine therapy for differentiated thyroid carcinoma and then treated with levothyroxine replacement therapy, in disease remission. The enrollment of patients who underwent total thyroidectomy allows that all possible variations in thyroid function are related only to the absorption of levothyroxine pharmacologically administered, in the absence of any interference from any residual intrinsic thyroid function. We will include hypothyroid patients, that accept to switch levothyroxine tablets with soft gel levothyroxine. We will not include women in pregnancy; it is expected the inclusion of women in childbearing age or during breastfeeding.

Epistemonikos ID: 51c3fc24bbc73eab95348134e467ed179716cacd
First added on: Aug 25, 2024