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 range2 Years – 16 Years

SexALL

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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.
✕. Previous participation in this study.

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