Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
04/08/2008
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 Centre
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
w.m.wiersinga@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC 03/119; NTR524

Study information

Scientific title

Acronym

EUGOGO study B

Study hypothesis

Antioxidants or anticytokines may suppress the autoimmune reaction in orbital tissues in Graves' orbitopathy patients.

Null hypothesis:
Selenium and pentoxifilline are as effective as placebo in mild Graves' orbitopathy.

Ethics approval

Ethics approval received from the local ethics committee

Study design

Multicentre, randomised, placebo controlled, double blind, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Graves' orbitopathy

Intervention

Group A: pentoxifylline 600 mg twice daily orally for 6 months
Group B: selenium selenite 100 µg twice daily orally for 6 months
Group C: placebo twice daily orally for 6 months

Intervention type

Drug

Phase

Not Specified

Drug names

Selenium, pentoxifylline

Primary outcome measures

Improvement in:
1. Lid apperture of at least 2 mm
2. Any of the class 2 signs by at least 1 grade
3. Proptosis by at least 2 mm
4. Any duction by at least 8 degrees
5. Improvement of 6 or more points on the Graves' Ophthalmopathy Quality Of Life Questionnaire (GO-QOL) scales

Secondary outcome measures

Improvement in:
1. The Gorman diplopia score
2. The 7 first items of the clinical activity score

Overall trial start date

01/11/2004

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Graves' hyperthyroidism, euthyroid for at least two months by antithyroid drugs or surgery (at least 6 months if I131 is used)
2. Mild Graves' ophthalmopathy (at least 1 sign), with a disease duration of less than 18 months
3. No past treatment of the ophthalmopathy except for local measures
4. Aged 18 - 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

156

Participant exclusion criteria

1. NOSPECS class 2c
2. Proptosis greater than 22 mm
3. Diplopia in primary or reading position and/or ocular torticollis
4. Mono-ocular duction in any direction of less than 20 degrees
5. Optic nerve involvement
6. Pregnancy, drugs/alcohol abuse, severe concomitant illness, no informed consent, use of selenium or pentoxifylline containing preparations

Recruitment start date

01/11/2004

Recruitment end date

01/11/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Other

Funder name

Expenses are being covered by the individual participating hospitals (The 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