Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof W.M. Wiersinga

ORCID ID

Contact details

Academic Medical Center
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR78; MEC number: 03/271

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, single blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Amiodarone-induced thyrotoxicosis type 2

Intervention

Treatment with:
1. Methimazole and prednisone
2. Methimazole and sodium perchlorate
3. Methimazole, sodium perchlorate and prednisone

Intervention type

Drug

Phase

Not Specified

Drug names

Methimazole, prednisone, sodium perchlorate

Primary outcome measures

Achievement of euthyroidism (TSH greater than 0.4 mE/L at 3 and 6 months).

Secondary outcome measures

Development side-effects.

Overall trial start date

01/03/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Thyroid stimulating hormone (TSH) less than 0.4 mE/L
2. Free thyroxine (FT4) greater than 25 pmol/l
3. Normal or raised triiodothyronine (T3)
4. Thyroid peroxidase antibodies less than 50 kU/l
5. Thyroid binding inhibitory immunoglobulins (TBII) less than 2.0 kU/l
6. Amiodarone use
7. Poor or no visualisation of thyroid gland on 99mTc-pertechnetate scintigraphy
8. No nodular goiter on ultrasound

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

1. Very critical illness
2. Drug or alcohol abuse
3. Pregnancy
4. No informed consent

Recruitment start date

01/03/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Internal Medicine
Meibergdreef 9
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes