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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. Identifier: NCT00917241
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : May 6, 2013
Information provided by (Responsible Party):
Xiao-Ming Mao, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Graves' Disease Drug: MMI combined with IID Drug: MMI Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: MMI
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.

Primary Outcome Measures :
  1. relapse of hyperthyroidism [ Time Frame: 4.5 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00917241

Sponsors and Collaborators
Xiao-Ming Mao
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Principal Investigator: Xiaoming Mao, M.D. Affiliated Nanjing First Hospital, Nanjing Medical University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Xiao-Ming Mao, Professor, Nanjing Medical University Identifier: NCT00917241    
Other Study ID Numbers: NanjingMU
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: June 2009
Keywords provided by Xiao-Ming Mao, Nanjing Medical University:
Graves' disease
Additional relevant MeSH terms:
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Graves Disease
Disease Attributes
Pathologic Processes
Orbital Diseases
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antithyroid Agents
Hormone Antagonists