A multicentre, open-label switch study to investigate the necessity of dose adjustment after switching from L-Thyroxine Christiaens® to the new levothyroxine sodium test formulation in (near) total thyroidectomised patients.

Takeda Belgium0 个研究点目标入组 101 人开始时间: 2013年4月29日最近更新: 2022年3月28日

适应症

试验速览

暂无简介。

•(Near) total thyroidectomised patients.
•Aged between 18 and 70 years.
•Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
•Written informed consent given.
•Able and willing to comply with protocol requirements and to complete the study.
•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 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•History of Graves’ disease or positive TSH-receptor antibodies.
•History of thyroid cancer requiring TSH suppression.
•Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
•Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
•Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
•Participation in another trial in the past 6 weeks.
•Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the CRF, as a possible explanation for change in lab parameters and/or dose switch)

发起方

Takeda Belgium