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
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