Patient that underwent a near total thyroidectomy and therefore are compelled to take levothyroxine hormone substition therapy. MedDRA version: 16.0 Level: LLT Classification code 10043777 Term: Thyroidectomy total System Organ Class: 100000004865 MedDRA version: 16.0 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: L-Thyroxine Christiaens
Product Name: levothyroxine test formulation
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVOTHYROXINE SODIUM
CAS Number: 55-03-8
Concentration unit: µg microg
Sponsors
Takeda Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the necessity of dose adjustment after switching (near) total thyroidectomised patients with stable TSH blood levels between 0.4-2.5 mIU/L under L- Thyroxine Christiaens® to the new levothyroxine sodium test formulation. ;Secondary Objective: To provide general practitioners and endocrinologists guidelines for dose adjustment based on the results of this study.;Primary end point(s): The proportion of patients that do not need a change of dose 2 months (± 2 weeks) after the switch.;Timepoint(s) of evaluation of this end point: 2 months (± 2 weeks) after the switch | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The magnitude of the change in daily dose needed 3 to 5 months after the switch. 2. Proportion of patients that obtained a TSH between 0.4-2.5 mU/L, 3 to 5 months after inclusion. 3. Change from baseline serum TSH (in mIU/L and percentage), at 2 (± 2 weeks) and 4 months (± 4 weeks) after inclusion. ;Timepoint(s) of evaluation of this end point: 1. 3 to 5 months after the switch 2. 3 to 5 months after inclusion 3. 2 (± 2 weeks) and 4 months (± 4 weeks) after inclusion | — |
Countries
Belgium
Contacts
Public ContactMedical Affairs Manager
Takeda Belgium
Outcome results
None listed