PatientsVille.com LogoPatientsVille.com

Paediatric Thyrotoxicosis | Antithyroid Drug Treatment of Thyrotoxicosis in Young People

Paediatric Thyrotoxicosis research study

What is the primary objective of this study?

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 is eligible to participate?

Inclusion Criteria: 1. 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). 2. Child has consented/assented or consent via parent/guardian has been gained prior to any study specific procedures Exclusion Criteria: 1. Known toxic adenoma / toxic hyperplasia (germline activating TSHR mutation). 2. McCune Albright Syndrome. 3. Previous episodes of Thyrotoxicosis.. 4. Known allergic response to any of the study medication or ingredients as per SmPC. 5. Previous participation in this study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Paediatric Thyrotoxicosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:Block and ReplaceThe 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 TitrationThe 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:carbimazoleCarbimazole 5mg and 20 mg tablets Administered as a once or twice daily regimen with total daily dose adjusted according to prevailing biochemistry

Drug:propylthiouracil50 mg tablets administered once daily with the dose adjusted according to the prevailing biochemistry

Drug:thyroxine25mcg, 50mcg and 100mcg tabletes administered once daily with the dose adjusted according to the prevailing biochemistry

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Block and ReplaceCarbimazole is commenced in a dose of 0.75 mg/kg/day. The intention is to completely prevent endogenous thyroxine production. Thyroxine is then added in a replacement dose as the thyroid hormone levels fall into the lower half of the laboratory normal range. The principal measure of control during the first 6 months will be thyroid hormone levels rather than TSH.

Dose TitrationCarbimazole 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 the euthyroid state. The principal 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. Drug: 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.

Study Status

Completed

Start Date: July 2004

Completed Date: November 2015

Phase: Phase 3

Type: Interventional

Design:

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

Secondary Outcome: Remission rates as defined by patients who are biochemically euthyroid at the end of the 4 year study period.

Study sponsors, principal investigator, and references

Principal Investigator: Tim Cheetham

Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01436994

Discuss Levothyroid