A Randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy. EUGOGO study B
Recruiting
- Conditions
- Mild Graves' orbitopathy
- Registration Number
- NL-OMON24865
- Lead Sponsor
- Prof. dr. W.M. WiersingaDept. of Endocrinology and MetabolismAcademic Medical CenterMeibergdreef 91105 AZ AmsterdamT: +31 20 5666071F: +31 20 6917682e-mail: w.m.wiersinga@amc.uva.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 156
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in:<br>1. lid apperture of at least 2 mm;<br>2. Any of the class 2 signs by at least 1 grade;<br>3. Proptosis by at least 2 mm;<br>4. any duction by at least 8 degrees;<br>5. Improvement of 6 or more points on the GO-QOL scales.
- Secondary Outcome Measures
Name Time Method Improvement in:<br>1. The Gorman diplopia score;<br>2. the 7 first items of the clinical activity score.