Status:

COMPLETED

Antithyroid Drug Treatment of Thyrotoxicosis in Young People

Lead Sponsor:

Newcastle-upon-Tyne Hospitals NHS Trust

Conditions:

Paediatric Thyrotoxicosis

Eligibility:

All Genders

2-16 years

Phase:

PHASE3

Brief 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 titrati...

Detailed Description

Thyrotoxicosis is an uncommon disorder in childhood and adolescence with a UK incidence around 1 per 100,000 (0-15 years). Most patients with thyrotoxicosis have Graves' disease which develops because...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2015

Estimated Enrollment :

81 Patients enrolled

Trial Details

Trial ID

NCT01436994

Start Date

July 1 2004

End Date

November 1 2015

Last Update

September 21 2016

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Royal Aberdeen Children's Hospital

Aberdeen, United Kingdom

2

Birmingham Children's Hospital

Birmingham, United Kingdom

3

Addebrookes Hospital

Cambridge, United Kingdom

4

Wales College of Medicine

Cardiff, United Kingdom

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