Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00917241|
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : May 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Drug: MMI combined with IID Drug: MMI||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||March 2009|
Experimental: MMI+IID group
MMI,methimazole；IID,intrathyroid injection of dexamethasone
Drug: MMI combined with IID
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.
Other Name: methimazole,tapazole;dexamethasone,hexadecadrol
Active Comparator: MMI Group
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.
- relapse of hyperthyroidism [ Time Frame: 4.5 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917241
|Principal Investigator:||Xiaoming Mao, M.D.||Affiliated Nanjing First Hospital, Nanjing Medical University|