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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05461820
Other study ID # 2016-SR-037
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2018
Est. completion date July 31, 2030

Study information

Verified date December 2023
Source The First Affiliated Hospital with Nanjing Medical University
Contact Xuqin Zheng
Phone 13912902902
Email zhengxuqin@njmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the dose of methimazole was adjusted according to the different states of thyroid function, and the effects of conventional therapy and intensive therapy on the cumulative recurrence of Graves' hyperthyroidism after two years of drug withdrawal were evaluated. At the same time, the changes of immune indexes and inflammatory factors in the regulation process were evaluated. This study is a phase IV clinical study designed and carried out by the First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), which is a randomized, open and routine treatment group with parallel control.


Description:

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Study Design


Intervention

Drug:
Methimazole
Methimazole used in this study was produced by Merck, Germany, and its trade name is Thyrozol. The specification of this drug is 10mg/ tablet, and its validity period is 36 months. It was approved by FDA in 2009 and listed in China in 2011.

Locations

Country Name City State
China the First Affiliated Hospital of Nanjing Medical University Nanjing

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative recurrence rate between conventional treatment group and intensive treatment group after two years of withdrawal. Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 2 years after the drug is stopped. Up to 2 years after drug withdrawal
Primary Number of patients with no adverse reactions during the treatment of Graves' disease The patient completed the methimazole treatment, and there were no adverse reactions that needed to be stopped. Adverse reactions refer to any symptoms, syndromes or diseases that affect patients' health during clinical research and observation, and also include clinically relevant situations found in the laboratory or other diagnostic processes, such as unplanned diagnosis and treatment measures, withdrawal from research, or clinically significant laboratory examination items. Blood routine, liver function, kidney function and adverse reactions will be recorded during the follow-up. Within the treatment period (average 2 years)
Secondary Cumulative recurrence rate of hyperthyroidism in conventional treatment group and intensive treatment group after stopping treatment for one year. Patients took medicine according to the course of treatment. Relapse occurs when the thyroid function returns to hyperthyroidism within 1 years after the drug is stopped. Up to 1 years after drug withdrawal
Secondary Effects of routine treatment and intensive treatment on titer and positive rate of thyroid autoantibodies Thyroid function and related antibodies were detected every 4 ~ 8 weeks, and the positive rate and titers of thyroid autoantibodies (including TPOAb, TGAb and TRAb) were compared. During treatment(average 2 years) and within 2 years after drug withdrawal
Secondary Effect of conventional therapy and intensive therapy on thyroid volume The changes of thyroid volume during treatment and withdrawal were compared. During treatment(average 2 years) and within 2 years after drug withdrawal
Secondary Effects of conventional therapy and intensive therapy on cytokines The changes of cytokines before and after different treatments were compared. During treatment(average 2 years) and within 2 years after drug withdrawal
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