Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
Primary Purpose
Graves' Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
MMI combined with IID
MMI
Sponsored by
About this trial
This is an interventional treatment trial for Graves' Disease focused on measuring Graves' disease, dexamethasone, relapse, methimazole
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed of Graves' Disease
Exclusion Criteria:
- Pregnancy
- Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range
- Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MMI+IID group
MMI Group
Arm Description
MMI,methimazole;IID,intrathyroid injection of dexamethasone
MMI,methimazole
Outcomes
Primary Outcome Measures
relapse of hyperthyroidism
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917241
Brief Title
Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
Official Title
Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiao-Ming Mao
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Antithyroid drugs are widely used in treatment of Graves' disease (GD), but after therapy withdrawal, relapse rate is very high. The aim this trail is to evaluate the effects of intrathyroid injection of dexamethasone combined with antithyroid drugs on patients with newly diagnosed GD.
Detailed Description
The morbility of GD is nearly 0.5% and the underlying cause of 50 to 80% of cases of hyperthyroidism.Recently,anti-thyroid drugs are still the main therapy for Graves'hyperthyroidism in a lot of districts, but the relapse rate is very high (51~68%) after withdrawal of anti-thyroid treatment.In order to reduce the relapse rate, some studies tried to prescribe replacement thyroxine, either with the anti-thyroid drug treatment, or after this was completed, but there is no clear evidence in favour of giving thyroid hormone supplementation following the initial treatment of Graves' thyrotoxicosis with anti-thyroid medication. Therefore, the optimal medical therapy for Graves' hyperthyroidism remains a subject of debate.
It is well known that glucocorticoids have anti-inflammatory, immunomodulation and immunosuppression effects and they has long been used to treat GO, and is one of the most effective medicine ,it can decrease some cytokines and reduce inflammatory status ,and improve some thyroid specific antibody, like as thyrotropin receptor antibodies (TRAb), antithyroperoxidase antibodies (TPOAb) and antithyroglobulin antibodies (TGAb).These studies suggested that glucocorticoids might affect autoimmune process and have some benefit effects on GD. Moreover glucocorticoids have been used to treat GD in several early reports, in which serum free triiodothyronine (FT3) and thyroxine (FT4) or total T3(TT3) and TT4 levels decreased after 8 days or three weeks treatment with glucocorticoids . But in those studies, the number of selected patients is small, and the duration of the therapy is relatively short, so that might not confirm the effects of glucocorticoids on GD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves' Disease
Keywords
Graves' disease, dexamethasone, relapse, methimazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMI+IID group
Arm Type
Experimental
Arm Description
MMI,methimazole;IID,intrathyroid injection of dexamethasone
Arm Title
MMI Group
Arm Type
Active Comparator
Arm Description
MMI,methimazole
Intervention Type
Drug
Intervention Name(s)
MMI combined with IID
Other Intervention Name(s)
methimazole,tapazole;dexamethasone,hexadecadrol
Intervention Description
MMI titration regimen for 18 months,initial dosage of MMI was 20 mg/d,which combined with IID for 3 months.Dexamethasone was injected into the two side of thyroid, the dose of dexamethasone was 5 mg by every side, twice a week. The treatment strategy was changed to once a week at the second month and twice a month at the third month, the dose of dexamethasone was the same as the first month.
Intervention Type
Drug
Intervention Name(s)
MMI
Intervention Description
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
Primary Outcome Measure Information:
Title
relapse of hyperthyroidism
Time Frame
4.5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed of Graves' Disease
Exclusion Criteria:
Pregnancy
Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range
Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Mao, M.D.
Organizational Affiliation
Affiliated Nanjing First Hospital, Nanjing Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
19850691
Citation
Mao XM, Li HQ, Li Q, Li DM, Xie XJ, Yin GP, Zhang P, Xu XH, Wu JD, Chen SW, Wang SK. Prevention of relapse of Graves' disease by treatment with an intrathyroid injection of dexamethasone. J Clin Endocrinol Metab. 2009 Dec;94(12):4984-91. doi: 10.1210/jc.2009-1252. Epub 2009 Oct 22.
Results Reference
derived
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Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
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