Morbus Basedow MedDRA version: 14.0 Level: PT Classification code 10004161 Term: Basedow's disease System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Selenase 300 RP
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Thyrozol® Filmtabletten
Product Name: T
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hyperthyroidism, defined as increased fT3 and TSH below 0.01mIU/L 2. Autoimmune Morbus Basedow: Positive TSH-R-Ab 3. Male and female patients of age: 18-80 years 4. Written informed consent given 5. No mental illness that prevents patients from comprehensive, written informed consent and study participation 6. Compliant patient, regular follow-up possible 7. For women with child-bearing potential: Effective method of contraception during the whole trial 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: 1. Pregnancy, breast-feeding women 2. Previous selenium or iodine intake within 4 weeks prior to study treatment 3. Pretreatment for Morbus Basedow with anti-thyroid drugs within 4 weeks prior to study treatment 4. Corticosteroids or other immunosuppressive agents because of M. Basedow extra-thyroid signs or another condition requiring therapy within 4 weeks prior to study treatment 5. Acute or chronic viral hepatitis 6. Relevant, actual malignant disease 7. Recent history of alcoholism or drug abuse 8. Participation in another clinical trial at the same time or = during the last 4 weeks 9. Allergic reactions or intolerance to previous trial medication exposure 10. Medical conditions which, according to the summary of product characteristics, the drugs are contraindicated for and if administered, cause a serious health risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Response rate at week 24: comparison of the combination treatment of anti-thyroid drug and selenium vs. anti-thyroid monotherapy (compared to baseline). Response rate is defined by euthyroidism: normal fT3, fT4 and TSH and negative TSH-R-Ab. - Relapse rate at week 36 (in both groups): Relapse rate is defined by change of thyroid related hormones and -antibodies (TSH, fT3, fT4, TSH-R-Ab) compared to week 24.;Secondary Objective: - Safety of the combination treatment of anti-thyroid drug and selenium. Safety is defined by change of liver values (Bilirubin, ALT, AST, ?GT, AP) and WBC. Safety will be determined on the week 0, 4, 12 and 24.;Primary end point(s): Response rate & Relapse rate;Timepoint(s) of evaluation of this end point: week 24 & week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of the combination treatment of anti-thyroid drug (Methimazole) and selenium.;Timepoint(s) of evaluation of this end point: week 4, 12, 24 | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
Universitätsmedizin Mainz, Dept. of Medicine I
Outcome results
None listed