Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients

Graves Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560299
• Other study ID #: Metiodine
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: March 20, 2012
• Start date: February 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65

• graves disease(TSH<0.1 &increased FT4 & positive TSI

• one or more bartlena criteria for radio-iodine therapy

• 24 hour RAIU>25%

• euthyroidism after methimazole treatment

Exclusion Criteria:

• pregnancy or lactation

• moderate or severe graves ophthalmopathy

• CHF or coronary heart disease

• palpable thyroid nodule

• lithium or amiodarone or lugol or ipodate treatment

• recent imaging with contrast agent

• very large goiter(more than 150 gram)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graves Disease

Intervention

Drug:
• Methimazole
Methimazole was stopped 24-48 before radio-iodine therapy
• Methimazole
methimazole discontinued 49-72 hours before radioiodine treatment
• Methimazole
methimazole discontinued 73-168 hours before radio-iodine treatment

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashad University of Medical Sciences	Mashad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thyroid function tests over one year after radioiodine therapy	thyroid function test may change over one year . In order to consider the patients as cured ,thyroid function tests should reveal hypothyroidism or euthyroidism . In order to rule out temporary hypothyroidism the tests should be repeated after 6 months of radioiodine therapy.	months 1 , 3 ,6,9,12	No