Substitutive and/or TSH suppressive therapy in thyroidectomized patients MedDRA version: 9.1 Level: LLT Classification code 10021117 Term: Hypothyroidism postoperative
Conditions
Interventions
Trade Name: Euthyrox 25 mcg
Pharmaceutical Form: Tablet
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Euthyrox 50 mcg
Pharmaceutical Form: Tabl
Sponsors
IBSA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Out-patients of both sexes; between 18 and 75 years of age; total thyroidectomy for any reasons, with consequent state of biological hypothyroidism; undetectable thyroglobulin levels 1 g/L or ng/mL and undetectable thyroglobulin autoantibodies by a sensitive immunoassay at screening; replacement/TSH suppressive therapy with T4 tablets stable for at least 3 months; adequate metabolic control; availability and possibility of taking part in the study; reasonable assumption of understanding the study and of reliability; written 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: seriously compromised cardiac heart failure , hepatic, renal, respiratory functions; serious metabolic e.g. uncompensated diabetes mellitus , organs e.g. cirrhosis of the liver , endocrine or systemic diseases excluding the basic pathology ; neoplastic diseases active or in remission for less than 5 years excluding the basic pathology ; terminal condition; parenteral or assisted enteral feeding; serious psychiatric problems whether or not being treated or compromising the patient s reliability; non-therapeutic use of psychotropic substances; alcoholism; pregnancy, current or planned within the next 12 months; breast-feeding; hypersensitivity to the ingredients of the preparations; concomitant medications interfering with the study evaluations; participation in other clinical studies in the two months preceding screening; presumption of poor reliability/co-operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to compare the therapeutic activity of L-thyroxine in soft capsule formulation for oral use IBSA T4 soft capsules with L-thyroxine in a tablet formulation.;Secondary Objective: the secondary objectives are to evaluate the safety of the new formulation and the level of acceptance of the latter by patients;Primary end point(s): To compare the therapeutic activity of T4 soft capsules and T4 tablets in terms of difference of serum levels of FT4 between start and end of a 6-month treatment period. | — |
Countries
France, Italy
Outcome results
None listed