No registrations found.
ID
Source
Brief title
Health condition
Mild Graves' orbitopathy
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Improvement in:
1. The Gorman diplopia score;
2. the 7 first items of the clinical activity score.
Background summary
A Randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy. EUGOGO study B.
Study objective
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.
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
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
P.O. Box 22660
W.M. Wiersinga
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5669111
w.m.wiersinga@amc.uva.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL482 |
| NTR-old | NTR524 |
| Other | : MEC 03/119 |
| ISRCTN | ISRCTN16320108 |