Clinical Trial Results:
The effect of intravenous glucocorticoids on the tearfilm in eyes with thyroid-associated ophthalmopathy
Summary
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EudraCT number |
2012-001910-40 |
Trial protocol |
AT |
Global end of trial date |
17 Jul 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jan 2020
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First version publication date |
26 Jan 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OPHT-120312
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienna, Austria,
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Public contact |
Univ. Klinik f. Klin. Pharmakologie, Medizinische Universität Wien, +43 1404002981, klin-pharmakologie@meduniwien.ac.at
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Scientific contact |
Univ. Klinik f. Klin. Pharmakologie, Medizinische Universität Wien, +43 1404002981, klin-pharmakologie@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Aug 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Jul 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Jul 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the change in tear film thickness in eyes with thyroid-associated ophthalmopathy treated with intravenous glucocorticoids
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Protection of trial subjects |
Subjects were during the trial continuously under the supervision of a physician or an experienced nurse.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jul 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited by use of the data base of the Clinical Pharmacology, Medical University of Vienna. | ||||||||||
Pre-assignment
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Screening details |
check of the In- and Exclusion criteria, physical examination, vital signs, laboratory assessment | ||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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One group | ||||||||||
Arm description |
A total of 24 patients will enter the trial. Only patients already scheduled for treatment with systemic glucocorticoids (according to the kahaly-scheme) will be included in the study. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Methylprednisolone (Urbason, Sanofi-Aventis)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500mg methylprednisolone iv once weekly for 6 weeks, followed by 250mg methylprednisolone iv once weekly for 6 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
One group
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Reporting group description |
A total of 24 patients will enter the trial. Only patients already scheduled for treatment with systemic glucocorticoids (according to the kahaly-scheme) will be included in the study. |
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End point title |
Tear film thickness measured with high resolution OCT [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
Evaluation after 6 and 12 weeks treatment
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: on account of early termination no statistical analysis have been made |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
27.06.2013-17.07.2018
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
22.1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Medication was well tolerated. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||||||
Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |