Efficacy and safety of combination therapy with methimazole and cholesterol absorption inhibitor in childhood Graves' disease

JRCT ID: jRCTs031180108

Registered date:05/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Graves' disease
• Date of first enrollment: 22/10/2014
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Colestimide 500mg tablet 2 times a day for 4 weeks

Outcome(s)

• Primary Outcome: The normalization rate of levels of free T4 and free T3 at the 4 weeks treatment

Secondary Outcome

Heart rate
Reduction rate of levels of free T3 and free T4
The normalization rate of levels of free T4 and free T3 at the 8, 12, and 24 weeks treatment
Changes of levels of TRAb, Total cholesterol, CPK, total bile acid and 25 hydroxy vitamin D

Key inclusion & exclusion criteria

• Age minimum: >= 10age old
• Age maximum: <= 16age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: NAGASAKI KEISUKE
• Secondary Sponsor: Hasegawa Yukihiro
• Source(s) of Monetary Support: The Ministry of Education, Culture, Sports, Science and Technology
• Secondary ID(s): UMIN000014383