Antithyroid Drug Treatment of Thyrotoxicosis in Young People

PHASE3CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

December 31, 2014

Study Completion Date

November 30, 2015

Conditions
Paediatric Thyrotoxicosis
Interventions
PROCEDURE

Block and Replace

The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range. Carbimazole is commenced in a dose of 0.75 mg/kg/day (propylthiouracil - for dose see below) with the aim being to completely preventing endogenous thyroxine production. Thyroxine is then added in a low replacement dose as the thyroid hormone levels fall into the lower half of the laboratory normal range. The principle measure of control during the first 6 months will be thyroid hormone levels rather than TSH. Carbimazole is the preferred treatment because of the increased risk of hepatotoxicity with propylthiouracil but patients who are treated with propylthiouracil can also be recruited and randomised. 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil.

PROCEDURE

Dose Titration

"The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range.~Carbimazole is commenced in a dose of 0.75 mg/kg/day until thyroid hormone levels fall into the local laboratory normal range. The dose is then reduced to 0.25 mg/kg/day with the intention of maintaining a euthyroid state as reflected by a free thyroxine and TSH within the normal range.~Most paediatricians in the UK commence thyrotoxic children on carbimazole rather than propylthiouracil. Carbimazole is the preferred treatment because of the increased risk of hepatotoxicity with propylthiouracil but patients who are treated with propylthiouracil can also be recruited and randomised. The guidelines detailed above can be used in the knowledge that 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil."

DRUG

carbimazole

Carbimazole 5mg and 20 mg tablets Administered as a once or twice daily regimen with total daily dose adjusted according to prevailing biochemistry

DRUG

propylthiouracil

50 mg tablets administered once daily with the dose adjusted according to the prevailing biochemistry

DRUG

thyroxine

25mcg, 50mcg and 100mcg tabletes administered once daily with the dose adjusted according to the prevailing biochemistry

Trial Locations (18)

Unknown

Royal Aberdeen Children's Hospital, Aberdeen

Birmingham Children's Hospital, Birmingham

Addebrookes Hospital, Cambridge

Wales College of Medicine, Cardiff

University Hospital, Coventry

Ninewells Hospital, Dundee

Royal Hospital for Sick Children, Edinburgh

Royal Hospital for Sick Children, Glasgow

Hereford Hospital, Hereford

Crosshouse Hospital, Kilmarnock

Alder Hey Children's Hospital, Liverpool

St Bart's Hospital, London

St George's Hospital, London

Royal Manchester Children's Hospital, Manchester

Royal Victoria Infirmary, Newcastle upon Tyne

Norfolk & Norwich University Hospitals, Norwich

Oxford Radcliffe Hospitals, Oxford

Sheffield Children's Hospital, Sheffield

All Listed Sponsors
lead

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

NCT01436994 - Antithyroid Drug Treatment of Thyrotoxicosis in Young People | Biotech Hunter | Biotech Hunter