NL-OMON24865
Recruiting
Not Applicable
A randomized placebo controlled double blind clinical trial comparing selenium and pentoxifylline in patients with mild Graves' orbitopathy.
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.nl0 sites156 target enrollmentTBD
ConditionsMild Graves' orbitopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Graves' orbitopathy
- 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
- Enrollment
- 156
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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