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
Conditions
Interventions
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:
Sponsors
PROF.EFISIO PUXEDDU, SEZIONE MEDICINA INTERNA SCIENZE ENDOCRINE E METABOLICHE, UNIVERSITà DI PERUGIA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: We will exclude all the patients on replacement therapy with levothyroxine in tablet form, which have not reached the therapeutic target (TSH levels between 0.8 and 1.6 mcU/ml) and that have had, in the prior 6 months, instability in levothyroxine dose to require frequent dose adjustments. We will also exclude all patients which take any drug at breakfast (or before or immediately after). Any drug eventually assumed is approved from one hour after breakfast. We will exclude patients with gastro-intestinal illnesses [6] or for malabsorption. We will exclude from enrollment patients with intolerance to the active substance or to any of the ingredients contained in the soft capsule, patients with concomitant untreated adrenal insufficiency, untreated hypopituitarism and untreated hyperthyroidism. We will also exclude patients with acute myocardial infarction, acute myocarditis or acute pancardite and patients unable to swallow a capsule. We will exclude the patients who didn't have surgical total thyroidectomy and patients who need suppressive therapy (patients with differentiated thyroid carcinoma in the first period after the initial treatment or patients with thyroid carcinoma with persistence or relapse of disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: to verify variation in quality of life related with variation of levothyroxine intaking time.;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).;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): there aren't secondary end points ;Timepoint(s) of evaluation of this end point: 0 | — |
Countries
Italy
Contacts
Public ContactProf. Efisio Puxeddu
Sezione Medicina Interna Scienze Endocrine e Metaboliche
Outcome results
None listed