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.

IBSA, Institut Biochimique SA0 个研究点目标入组 205 人开始时间: 2007年6月20日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•-outpatients, either men or women between 18 and 75
•- Having undergone a total hypothyrodism, whatever the reason is, having consequently ahypothyroidism biological state.
•- undectable rate in thyroglobulin (<1 microgram/L) and self-antibodies of the thyroglobulin during the selection
•- substitutive treatment or suppression of TSH with T4 tablets at a stable dosis at least for 3 months, stable metabolic status, patient who is available to take part to the study and able to understand the protocol and to respect it.
•- patient who has given his/her written 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

•-Functional severe cardiac (cardiac insufficiency), renal, respiratory hepatitic problems
•-metabolic diseases (e.g. unbalanced diabet of type II) organic (liver cirrhosis), endocrinal or systemic diseases (except the disease under study), current or abated neoplastic diseases for less than 5 years (except the disease un der study)
•-terminal phase
•-patient under parental or assisted nutrition
•-pregnant women or likely to become in the next 12 months
•-lactating women

发起方

IBSA, Institut Biochimique SA