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Comparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C


- candidate number1876
- NTR NumberNTR525
- ISRCTNISRCTN17061437
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR1-dec-2005
- Secondary IDsMEC 05/101 
- Public TitleComparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
- Scientific TitleComparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
- ACRONYMEUGOGO study C
- hypothesisThe hypothesis is that cummulative doses of 2.5, 5.0 or 7.5 gram methylprednisolone infusions are equally effective in moderately severe Graves' ophthalmopathy, but that the doses differ in the number and severity of side effects.
- Healt Condition(s) or Problem(s) studiedSevere Graves' orbitopathy
- Inclusion criteria1. Graves' hyperthyroidism, euthyroid for at least two months by antithyroid drugs or surgery (at least 6 months if I131 is used; 2. Moderately severe Graves' ophthalmopathy defined as having at least one of the following signs: a. class 2b-c b. mono-ocular duction <30 degrees c. diplopia Gorman score grade a-c; 3. Active Graves' ophthalmopathy (CAS 3 or higher out of 7); 4. No past treatment of the ophthalmopathy except for local measures; 5. Age 18-70 years.
- Exclusion criteria1. CAS <3; 2. Clinically relevant optic nerve involvement; 3. General contra-indications to glucocorticoid infusions; 4. Pregnancy; 5. No informed consent; 6. Viral hepatitis; 7. Liver enzymes increased by a factor 2.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 21-sep-2005
- planned closingdate1-okt-2008
- Target number of participants159
- InterventionsTreatment with weekly methylprednisolone iv infusions, total dose 2.5, 5.0 or 7.5 gram during 12 weeks
- Primary outcome1. Efficacy Improvement in: a. lid aperture of at least 3 mm b. 2 or more degrees of class 2 signs c. proptosis by at least 2 mm d. any duction by at least 8 degrees or improvement in diplopia score e. CAS by at least 2 points f. improvement of 6 or more points on the GO-QOL scales. 2. Safety safety score (2 points to each major side effect and 1 point to each minor side effect).
- Secondary outcomeN/A
- 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 summaryComparison of the effectiveness and tolerability of different doses of intravenous glucocorticoid for the treatment of moderately severe Graves' ophthalmopathy. EUGOGO study C
- Main changes (audit trail)
- RECORD6-dec-2005 - 6-mrt-2006


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