A randomised placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy - EUGOGO study B

ISRCTN	ISRCTN16320108
DOI	https://doi.org/10.1186/ISRCTN16320108
Protocol serial number	MEC 03/119; NTR524
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Expenses are being covered by the individual participating hospitals (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof W.M. Wiersinga
Scientific

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

Email	w.m.wiersinga@amc.uva.nl

Primary study design	Interventional
Study design	Multicentre, randomised, placebo controlled, double blind, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EUGOGO study B
Study objectives	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(s)	Ethics approval received from the local ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Selenium, pentoxifylline
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Improvement in: 1. The Gorman diplopia score 2. The 7 first items of the clinical activity score
Completion date	01/11/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	156
Key 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
Key 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
Date of first enrolment	01/11/2004
Date of final enrolment	01/11/2008

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan