Multicentre, controlled, randomised, open-label, cross-over clinical study of the efficacy and tolerability of L-thyroxine T4 soft capsules, in comparison to L-thyroxine tablets, in thyroidectomised patients. - ND

• Conditions: Substitutive and/or TSH suppressive therapy in thyroidectomized patients; MedDRA version: 9.1Level: LLTClassification code 10021117Term: Hypothyroidism postoperative

• Registration Number: EUCTR2006-002614-36-IT
• Lead Sponsor: IBSA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

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.

Study & Design

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