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

• Conditions: Hypothyroidism; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-000759-41-IT
• Lead Sponsor: Fondazione Toscana Gabriele Monasterio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-21
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

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