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

NCT ID: NCT01560299

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graves Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group one

This group will be advised to discontinue methimazole 24-48 hour before iodine therapy

Group Type ACTIVE_COMPARATOR

Methimazole

Intervention Type DRUG

Methimazole was stopped 24-48 before radio-iodine therapy

group two

methimazole stopped 48-72 hour before radioiodine therapy

Group Type ACTIVE_COMPARATOR

Methimazole

Intervention Type DRUG

methimazole discontinued 49-72 hours before radioiodine treatment

group three

Group Type ACTIVE_COMPARATOR

Methimazole

Intervention Type DRUG

methimazole discontinued 73-168 hours before radio-iodine treatment

Interventions

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Methimazole

Methimazole was stopped 24-48 before radio-iodine therapy

Intervention Type DRUG

Methimazole

methimazole discontinued 49-72 hours before radioiodine treatment

Intervention Type DRUG

Methimazole

methimazole discontinued 73-168 hours before radio-iodine treatment

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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S.R.ZAKAVI

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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rasoul zakavi, associate professor

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Sciences

Locations

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Mashad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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Metiodine

Identifier Type: -

Identifier Source: org_study_id

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