Antioxidants 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.
ID
Bron
Verkorte titel
Aandoening
Mild Graves' orbitopathy
Ondersteuning
Dept. of Endocrinology and Metabolism
Academic Medical Center
Meibergdreef 9
1105 AZ Amsterdam
T: +31 20 5666071
F: +31 20 6917682
e-mail: w.m.wiersinga@amc.uva.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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 GO-QOL scales.
Achtergrond van het onderzoek
A Randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy. EUGOGO study B.
Doel van het onderzoek
Antioxidants 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.
Onderzoeksproduct en/of interventie
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
Algemeen / deelnemers
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
Wetenschappers
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL482 |
| NTR-old | NTR524 |
| Ander register | : MEC 03/119 |
| ISRCTN | ISRCTN16320108 |