Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiao-Ming Mao, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00917241
First received: June 9, 2009
Last updated: May 2, 2013
Last verified: June 2009
  Purpose

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 Intervention Phase
Graves' Disease
Drug: MMI combined with IID
Drug: MMI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention Relapse of Graves' Disease by Treatment With Intrathyroid Injection of Dexamethasone

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • relapse of hyperthyroidism [ Time Frame: 4.5 year ] [ Designated as safety issue: Yes ]

Enrollment: 218
Study Start Date: June 2004
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,methimazole
Drug: MMI
MMI treatment with titration regimen for 18 months, initial dosage was 20 mg/d.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00917241

Sponsors and Collaborators
Xiao-Ming Mao
Investigators
Principal Investigator: Xiaoming Mao, M.D. Affiliated Nanjing First Hospital, Nanjing Medical University
  More Information

No publications provided by Nanjing Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xiao-Ming Mao, Professor, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00917241     History of Changes
Other Study ID Numbers: NanjingMU
Study First Received: June 9, 2009
Last Updated: May 2, 2013
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Medical University:
Graves' disease
dexamethasone
relapse
methimazole

Additional relevant MeSH terms:
Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Methimazole
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014