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
Secondary identifying numbers MEC 03/119; NTR524
Submission date
14/02/2006
Registration date
14/02/2006
Last edited
04/08/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
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

Contact information

Prof W.M. Wiersinga
Scientific

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

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

Study information

Study designMulticentre, randomised, placebo controlled, double blind, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymEUGOGO study B
Study objectivesAntioxidants 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) studiedGraves' orbitopathy
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Selenium, pentoxifylline
Primary outcome measureImprovement 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 measuresImprovement in:
1. The Gorman diplopia score
2. The 7 first items of the clinical activity score
Overall study start date01/11/2004
Completion date01/11/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants156
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2004
Date of final enrolment01/11/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

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

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Other

Expenses are being covered by the individual participating hospitals (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan