Toxic Nodular GoitrePhase 4NCT00150137
Antithyroid Drugs During Radioiodine Therapy
A Phase 4 study testing Methimazole in people with Toxic Nodular Goitre and Graves Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Toxic Nodular Goitre, Graves Disease
- What is being tested?
- Methimazole
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2003to Dec 2004
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter.
Who cannot join
- Age < 18 yrs.
- Allergy to anti-thyroid drugs
- Substernal or large (> 100ml) goiter
- Severe endocrine ophthalmopathy
- Pregnancy or lactation
- Suspicion of thyroid malignancy
- Unsafe contraconception
- Physical or mental condition that hinders corporation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Odense University Hospital
Odense, Funen, 5000
About this study
Official title: The Influence of Continuous Treatment With Antithyroid Drugs on the Effect of Radioiodine in Patients With Hyperthyroidism
Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome.
Aim: To clarify by a randomized trial whether continuous use of methimazole during radioiodine therapy influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.
Patients and Methods: 80 consecutive patients suffering from recurrent Graves' disease or a toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.
- Conditions
- Toxic Nodular Goitre, Graves Disease
- Being tested
- Methimazole
- Keywords
- Radioiodine therapy, Graves' disease, toxic nodular goiter, antithyroid drugs, radioprotection
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid function after one year of follow-up
Secondary outcomes (2)
Thyroid radioiodine 131I uptake
Thyroid volume after one year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxic Nodular GoitreStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Steen J Bonnema, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150137
- Sponsor's protocol ID
- 013
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 3 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Continuous Treatment With Antithyroid Drugs on the Effect of Radioiodine in Patients With Hyperthyroidism
- ClinicalTrials.gov ID
- NCT00150137
- Acronym / sponsor ID
- 013
- Conditions
- Toxic Nodular Goitre, Graves Disease
- Keywords
- Radioiodine therapy, Graves' disease, toxic nodular goiter, antithyroid drugs, radioprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Dec 2004
- First posted
- 8 Sep 2005 (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.
Background: The use of radioactive iodine (131I) therapy as the definite cure of hyperthyroidism is widespread. According to a survey on the management of Graves' disease, thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs (ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced 'thyroid storm', which, however, is rarely encountered. Several studies have consistently shown that patients who are treated with ATD prior to 131I therapy have an increased risk of treatment failure. Mostly, patients with Graves' disease have been studied, while other studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD have 'radioprotective' properties, although this view is almost exclusively based on retrospective data and is still under debate (13). Indeed, this dogma was recently challenged by two randomized trials in Graves' disease, none of which showed such an adverse effect of methimazole pretreatment. It cannot be excluded that the earlier results may have been under influence of selection bias, a source of error almost unavoidable in retrospective studies. Whether ATD is radioprotective also when used in the post 131I period has also been debated. In the early period 131I therapy following a transient rise in the thyroid hormones is seen which may give rise to discomfort in some patients. The continuous use of ATD during 131I therapy leads to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy, euthyroidism can usually be maintained until the destructive effect of 131I ensues. Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the evidence is based on retrospective studies and the ideal set-up should be reconsidered. To underscore the importance of performing randomized trials we showed recently that resumption of methimazole seven days after 131I therapy had no influence on the final outcome.
Aim: To clarify by a randomized trial whether continuous use of methimazole during radioiodine therapy influences the final outcome of this therapy, in a comparison with a regime in which methimazole as mono-therapy is discontinued 8 days before radioiodine.
Patients and Methods: 80 consecutive patients suffering from recurrent Graves' disease or a toxic nodular goiter are included. All patients are rendered euthyroid by methimazole (MMI) and randomized either to stop MMI eight days before 131I or to continue MMI until four weeks after 131I. Calculation of the 131I activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume. Patients are followed for one year with close monitoring of the thyroid function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter.
Key exclusion criteria (8 listed)
- Age < 18 yrs.
- Allergy to anti-thyroid drugs
- Substernal or large (> 100ml) goiter
- Severe endocrine ophthalmopathy
- Pregnancy or lactation
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 |
|---|---|---|
| Methimazole | Drug | – |
Primary outcome
Thyroid function after one year of follow-up
2 secondary outcomes
Thyroid radioiodine 131I uptake
Thyroid volume after one year of follow-up
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 3 Feb 2006.
Related trials for Toxic Nodular Goitre
RecruitingPhase 3
Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
Hyperthyroidism
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.
Steen J Bonnema, MD, PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methimazole in people with Toxic Nodular Goitre and Graves Disease, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 8 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 3 Feb 2006. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 after one year of follow-up. 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 3 Feb 2006.