Graves DiseaseNCT01560299
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
A study testing Methimazole in people with Graves Disease, run by Mashhad University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- Methimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 91766
About this study
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.
- Conditions
- Graves Disease
- Being tested
- Methimazole
- Keywords
- hyperthyroidism, radio-iodine, I-131, methimazole, graves disease
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
Methimazole was stopped 24-48 before radio-iodine therapy
MethimazoleDrug
methimazole discontinued 49-72 hours before radioiodine treatment
MethimazoleDrug
methimazole discontinued 73-168 hours before radio-iodine treatment
| Study group | Role | What they receive |
|---|---|---|
| group one | Active comparator | This group will be advised to discontinue methimazole 24-48 hour before iodine therapy Receives: Drug: Methimazole |
| group two | Active comparator | methimazole stopped 48-72 hour before radioiodine therapy Receives: Drug: Methimazole |
| group three | Active comparator | Not described Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: months 1 , 3 ,6,9,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.R.ZAKAVI, Mashhad University of Medical Sciences
- Investigators
- rasoul zakavi, associate professor, Principal investigator, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560299
- Sponsor's protocol ID
- Metiodine
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
- ClinicalTrials.gov ID
- NCT01560299
- Acronym / sponsor ID
- Metiodine
- Conditions
- Graves Disease
- Keywords
- hyperthyroidism, radio-iodine, I-131, methimazole, graves disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group one | Active comparator | Drug: MethimazoleThis group will be advised to discontinue methimazole 24-48 hour before iodine therapy |
| group two | Active comparator | Drug: Methimazolemethimazole stopped 48-72 hour before radioiodine therapy |
| group three | Active comparator | Drug: Methimazole |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- pregnancy or lactation
- moderate or severe graves ophthalmopathy
- CHF or coronary heart disease
- palpable thyroid nodule
- lithium or amiodarone or lugol or ipodate treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethimazoleMethimazole was stopped 24-48 before radio-iodine therapy | Drug | group one |
| Methimazolemethimazole discontinued 49-72 hours before radioiodine treatment | Drug | group two |
| Methimazolemethimazole discontinued 73-168 hours before radio-iodine treatment | Drug | group three |
Primary outcome
thyroid function tests over one year after radioiodine therapy
Time frame: months 1 , 3 ,6,9,12
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rasoul zakavi, associate professor principal investigator
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methimazole in people with Graves Disease, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thyroid function tests over one year after radioiodine therapy (time frame: months 1 , 3 ,6,9,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.