CompletedPhase 3

Antithyroid Drug Treatment of Thyrotoxicosis in Young People

United Kingdom81 participantsStarted 2004-07

Plain-language summary

The investigators aim to establish whether biochemical control during anti-thyroid drug therapy in young people with thyrotoxicosis varies depending upon whether a 'block and replace' or 'dose titration' regimen is used. The investigators will also assess remission rates and the frequency of side-effects in the two treatment groups.

Who can participate

Age range

2 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All patients with thyrotoxicosis aged between 2 and 16 years at the time of diagnosis. Thyrotoxicosis will be diagnosed by the paediatrician on the basis of the clinical picture and the biochemistry (suppressed TSH with high thyroid hormone levels).
. Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures

Exclusion criteria

. Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation).
. McCune Albright Syndrome.
. Previous episodes of Thyrotoxicosis..
. Known allergic response to any of the study medication or ingredients as per SmPC.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Biochemical control as reflected by the stability of blood thyroid stimulating hormone (TSH) concentrations

Timeframe: 2.5 years

Trial details

NCT IDNCT01436994

SponsorNewcastle-upon-Tyne Hospitals NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Paediatric Thyrotoxicosis trials