A prospective, open-label, single center, cross-over, controlled, randomized, phase III study to test superiority of the oral solution of synthetic thyroxine compared to tablet preparation for treatment of hypothyrod patients under chronic gastric pump inhibitors treatment

A prospective, open-label, single center, cross-over, controlled, randomized, phase III study to test superiority of the oral solution of synthetic thyroxine compared to tablet preparation for treatment of hypothyrod patients under chronic gastric pump inhibitors treatment - THYLITABOR

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000759-41-IT

Enrollment

Registered

2013-08-21

Start date

2014-03-27

Completion date

Unknown

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism

Interventions

Trade Name: Tirosint 100 mcg/1 ml 30 single-dose containers 1ml Product Name: Tirosint 100 mcg/1 ml 30 single-dose containers 1 ml Pharmaceutical Form: Oral solution INN or Proposed INN: LEVOTHYROXINE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age range: 20-80 years, 2) first diagnosis of primary hypothyroidism, 3) chronic consumption of of PPI (ATC A02BC) for at least 3 month before enrolment, 4) signed informed consent 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 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: 1) amiodarone treatment; 2) presence of decompensated diabetes (glycated Hb A1c >8%); 3) severe liver (i.e. transaminases SGOT/SGPT > 100 U/l and/or gamma GT > 150 U/l) and renal disease (i.e. creatinine > 2 mg/dl); 4) active neoplastic disease including thyroid cancer; 5) documented active bacterium pylori gastritis; 6) concomitant use of other already know drugs able to interfere L-T4 absorption (Sucralfate, Aluminum containing antacids, Bile acid sequestrants, Calcium carbonate, Raloxifene); 7) pregnant or breast-feeding women 8) mental incapability to sign informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) to evaluate the bioequivalence of identical substitutive doses of commercially available oral L-T4, when utilized in different formulation (tablets vs oral solution) by evaluating target concentrations of the utilized markers of thyroid function (circulating FT4 FT3 TSH) in hypothyroid patients, independently of concomitant treatments for comorbidities 2) to evaluate if the pre-existing conventional oral chronic treatment with PPIs may induce changes in dosage of tablets or oral solution to maintain superimposable levels of FT4 FT3 and, in particular, of TSH ;Secondary Objective: 1) to evaluate if the pre-existing conventional oral chronic treatment with PPIs may induce changes in a dose-dependent manner in dosage of tablets or oral solution containing L-T4 to maintain superimposable levels of FT4 FT3 and in particular of TSH 2) to evaluate if biohumoral and instrumental parameters related to thyroid action in peripheral main target tissues (i.e. cardiac, brain and bone tissues) will change according to the different doses of L-T4 utilized to maintain superimposable biochemical pattern of thyroid state (i.e. FT4 FT3 TSH circulating levels) ;Primary end point(s): 1)Stable TSH values ranging from 1 to 2 microIU/ml after treatment 2)Normal values of both FT3 and FT4 with stable TSH >1<2 microU/ml ;Timepoint(s) of evaluation of this end point: 24 weeks	—

Measure

Time frame

Main Objective: 1) to evaluate the bioequivalence of identical substitutive doses of commercially available oral L-T4, when utilized in different formulation (tablets vs oral solution) by evaluating target concentrations of the utilized markers of thyroid function (circulating FT4 FT3 TSH) in hypothyroid patients, independently of concomitant treatments for comorbidities 2) to evaluate if the pre-existing conventional oral chronic treatment with PPIs may induce changes in dosage of tablets or oral solution to maintain superimposable levels of FT4 FT3 and, in particular, of TSH ;Secondary Objective: 1) to evaluate if the pre-existing conventional oral chronic treatment with PPIs may induce changes in a dose-dependent manner in dosage of tablets or oral solution containing L-T4 to maintain superimposable levels of FT4 FT3 and in particular of TSH 2) to evaluate if biohumoral and instrumental parameters related to thyroid action in peripheral main target tissues (i.e. cardiac, brain and bone tissues) will change according to the different doses of L-T4 utilized to maintain superimposable biochemical pattern of thyroid state (i.e. FT4 FT3 TSH circulating levels) ;Primary end point(s): 1)Stable TSH values ranging from 1 to 2 microIU/ml after treatment 2)Normal values of both FT3 and FT4 with stable TSH >1<2 microU/ml ;Timepoint(s) of evaluation of this end point: 24 weeks

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 24 weeks;Secondary end point(s): 1)TSH values reached by identical doses of L-T4 (tablet vs oral monodose solution) are dose-dependent related to PPI	—

Countries

Italy

Contacts

Public ContactFarmacia

Fondazione Toscana Gabriele Monasterio

stefania.biagini@ftgm.it390585493507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026