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


- candidate number1875
- NTR NumberNTR524
- ISRCTNISRCTN16320108
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR1-dec-2005
- Secondary IDsMEC 03/119 
- Public TitleA Randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy. EUGOGO study B
- Scientific TitleA randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy.
- ACRONYMEUGOGO study B
- hypothesisAntioxidants or anticytokines may suppress the autoimmune reaction in orbital tissues in Graves' orbitopathy patients. Nul hypothesis: selenium and pentoxifilline are as effective as placebo in mild Graves' orbitopathy.
- Healt Condition(s) or Problem(s) studiedGraves' orbitopathy
- Inclusion criteria1. Graves' hyperthyroidism, euthyroid for at least two months by antithyroid drugs of 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. Age 18-70 years.
- Exclusion criteria1. NOSPECS class 2c; 2. Proptosis >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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-nov-2008
- Target number of participants156
- InterventionsGroup A: pentoxifylline 600 mg twice daily orally for 6 months Group B: selenium selenite 100 g twice daily orally for 6 months Group C: placebo twice daily orally for 6 months
- Primary outcomeImprovement 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 GO-QOL scales.
- Secondary outcomeImprovement in: 1. The Gorman diplopia score; 2. the 7 first items of the clinical activity score.
- Timepoints
- Trial web sitehttp://www.eugogo.org
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.M. Wiersinga
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.M. Wiersinga
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsN/A
- Brief summaryA Randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy. EUGOGO study B.
- Main changes (audit trail)
- RECORD1-dec-2005 - 6-mrt-2006


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