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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-003678-82-NL |
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Date of registration:
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02/04/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency
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Scientific title:
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Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency |
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Date of first enrolment:
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10/07/2007 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003678-82 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Patients aged 0-17 years
- Must have an indication for a growth hormone stimulation test to investigate a possible growth hormone deficiency, and this is to be decided by or under supervision of a staff paediatrician, paediatric endocrinologist or fellow
- Written informed consent from parents or legal guardian, in the case of a child aged 12 years or older written informed consent from both parents/legal guardian and the child
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
None
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Clonidine is studied in the paediatric population, more specific children with short stature. It is used as a diagnostic tool to establish Growth Hormone reserve in routine practice.
MedDRA version: 8.1
Level: LLT
Classification code 10005573
Term: Blood growth hormone decreased
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Intervention(s)
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Trade Name: Catapresan
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Main Objective: (1) To establish the concentration time profile of orally administered clonidine in the hours following administration
(2) To assess the pharmacodynamic response following oral clonidine administration with particular attention for: Depth of sedation, Haemodynamic parameters (including heart rate variability), Growth hormone response, serum cortisol response and serum glucose response.
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Primary end point(s): Primary study endpoints
• Pharmacokinetics of clonidine following oral administration
• Growth hormone response following oral administration of clonidine
• Cortisol response following oral administration of clonidine
• Sedation depth following clonidine oral administration, measured with modified Ramsay Sedation Scale
• Hemodynamic and respiratory parameters (Blood Pressure, Heart Rate, Transcutaneous oxygen saturation) following oral administration of clonidine
Secondary study endpoints
• Basal ACTH
• Heart rate variability
• QTc times before and after clonidine administration
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Secondary Objective:
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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