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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
Xiao-Ming Mao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graves' Disease focused on measuring Graves' disease, dexamethasone, relapse, methimazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 9, 2009
    Last Updated
    May 2, 2013
    Sponsor
    Xiao-Ming Mao
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    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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