A randomised placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy - EUGOGO study B
ISRCTN | ISRCTN16320108 |
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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
Scientific
Academic Medical Centre
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
w.m.wiersinga@amc.uva.nl |
Study information
Study design | Multicentre, randomised, placebo controlled, double blind, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Selenium, pentoxifylline |
Primary outcome measure | 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 study start date | 01/11/2004 |
Completion date | 01/11/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Endocrinology and Metabolism
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.uva.nl |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |