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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR525 |
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Date of registration:
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01/12/2005 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - EUGOGO study C |
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Date of first enrolment:
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21/9/2005 |
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Target sample size:
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159 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=525 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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W.M.
Wiersinga |
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Address:
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Academic Medical Center (AMC), Department of Endocrinology and Metabolism,
P.O. Box 22660, Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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w.m.wiersinga@amc.uva.nl |
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Affiliation:
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Name:
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W.M.
Wiersinga |
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Address:
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Academic Medical Center (AMC), Department of Endocrinology and Metabolism,
P.O. Box 22660, Meibergdreef 9
1105 AZ
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5669111 |
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Email:
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w.m.wiersinga@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Severe Graves' orbitopathy
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Intervention(s)
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Treatment with weekly methylprednisolone iv infusions, total dose 2.5, 5.0 or 7.5 gram during 12 weeks
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Primary Outcome(s)
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1. 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).
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Secondary ID(s)
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ISRCTN17061437
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MEC 05/101
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Source(s) of Monetary Support
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None
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