Prevention Relapse of Graves' Disease by Intrathyroid Injection of Dexamethasone

NCT00917241 | Completed Phase 4

• 1 other identifier: NanjingMU
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graves' Disease

Keywords

Graves' disease; dexamethasone; relapse; methimazole

Outcome Measures

Primary Outcomes (1)

• relapse of hyperthyroidism

  4.5 year

Study Arms (2)

MMI+IID group

EXPERIMENTAL

MMI,methimazole；IID,intrathyroid injection of dexamethasone

Drug: MMI combined with IID

MMI Group

ACTIVE COMPARATOR

MMI,methimazole

Drug: MMI

Interventions

MMI combined with IID DRUG

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.

Also known as: methimazole,tapazole;dexamethasone,hexadecadrol

MMI+IID group

MMI DRUG

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

MMI Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed of Graves' Disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiao-Ming Mao: lead

Related Publications (1)

• 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.

  PMID: 19850691 DERIVED

MeSH Terms

Conditions

Graves Disease; Recurrence

Interventions

Methimazole

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaoming Mao, M.D.

  Affiliated Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 10, 2009
• Study Start: June 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: May 6, 2013

Record last verified: 2009-06