Efficacy and safety of combination therapy with methimazole and cholesterol absorption inhibitor in childhood Graves' disease
- Conditions
- Graves' diseaseEndocrinology and Metabolism, PediatricsD006111
- Registration Number
- JPRN-jRCTs031180108
- Lead Sponsor
- AGASAKI KEISUKE
- Brief Summary
The superiority of the MMI and cholesterol absorption inhibitor combination group compared to the MMI monotherapy group was not verified in patients with newly diagnosed childhood-onset Graves' disease with moderate or severe thyrotoxicosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 69
1) Patients with newly diagnosed Graves' disease
2) Serum FT4 value more than 5.0 ng/dl
3) Written informed consent from the patients' parents or legal guardians.
4) Age from 10 years old to under 16 years old
1) Patients with thyrotoxic crisis
2) Patients who receive pharmacotherapy for diabetes, hepatic and renal disease
3) Medical history of Graves' disease. Patients who have already used cholesterol absorption inhibitor.
4) Use of coumarin anticoagulants, digitalis, and bile acids preparations
5) Patients with complete obstruction of the biliary tract
6) Patients with intestinal obstruction
7) Judged inappropriate for this study by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The normalization rate of levels of free T4 and free T3 at the 4 weeks treatment
- Secondary Outcome Measures
Name Time Method Heart rate<br>Reduction rate of levels of free T3 and free T4<br>The normalization rate of levels of free T4 and free T3 at the 8, 12, and 24 weeks treatment<br>Changes of levels of TRAb, Total cholesterol, CPK, total bile acid and 25 hydroxy vitamin D