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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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25 September 2012 |
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Main ID: |
EUCTR2008-004849-28-HU |
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Date of registration:
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03/06/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Scientific title:
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A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency -
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Date of first enrolment:
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09/07/2009 |
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Target sample size:
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138 |
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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:2008-004849-28 |
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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: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Hungary
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion criteria Pre-screening:
1.Signed informed consent and obtained assent.
2.Children aged = 3 years and not above 10 years for girls or 11 years for boys at the Pre-screening visit.
3.A positive locally performed GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s)) prior to the Pre-screening visit.
4.Height SDS < -2 SD of reference value for chronological age (CA)
5.Height velocity SDSCA = 0 SD of reference value for at least 6 months prior to the Pre-screening visit
6.Height recorded for at least 6 months but performed no more than 18 months before the Pre-screening visit.
Inclusion criteria Screening:
7.Reconfirmed signed informed consent and obtained assent
8.The difference between CA-BA = 1.
9.Idiopathic GH deficiency confirmed during the Pre-screening period by a standard GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s))
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:
Exclusion criteria Pre-screening:
1.Any prior treatment with GH
2.Any diagnosed or suspected syndrome (e.g. Silver-Russell, Turner’s or Seckel syndrome) which possibly could affect growth
3.Any other diagnosed or suspected endocrine or metabolic disorder (e.g. Prader-Willi syndrome, diabetes mellitus or Cushing’s syndrome)
4.Any diagnosed or suspected severe chronic disease
5.Clinical signs of dysmorphic features, malformations or mental retardation
6.Growth failure due to other disorders (emotional deprivation, severe chronic illness, malnutrition or chondrodysplasia)
7.Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
8.Diagnosed malignant disease
9.Any known hypersensitivity to somatropin or any of the excipients of ZOMACTON and GENOTROPIN.
Exclusion criteria Screening:
10.BA above 9 years in girls and above 10 years in boys (to exclude pubertal growth)
11.Puberty Tanner Stage > I
12.Weight < 12 kg at the Screening visit
13.Closed epiphysis
14.Any abnormal clinically significant lab results that requires further investigation
15.Receipt of an investigational drug within the last 28 days preceding Screening or longer if considered to possibly influence the outcome of the current trial.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Idiopathic growth hormone deficiency.
MedDRA version: 9.1
Level: LLT
Classification code 10056438
Term: Growth hormone deficiency
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Intervention(s)
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Trade Name: Zomacton 10 mg/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629015
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Genotropin 12 mg/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629015
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 12-
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Primary Outcome(s)
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Main Objective: To demonstrate that one daily dose of ZOMACTON (10 mg/mL) is equivalent to one daily dose of GENOTROPIN (12 mg/mL) in terms of growth measured as height velocity based on 12 months of treatment.
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Secondary Objective: 1. To investigate the efficacy of one daily dose of ZOMACTON compared with one daily dose of GENOTROPIN measured as an increase in height SDS during 12 months of treatment.
2. To investigate the efficacy of one daily dose of ZOMACTON compared with one daily dose of GENOTROPIN measured as an increase in height velocity SDS during 12 months of treatment.
3. To investigate the effect of ZOMACTON versus GENOTROPIN on the serum levels of IGF-1 and IGFBP-3 during 12 months as compared to baseline.
4.To investigate the ?bone age (?BA) at 12 months as compared to baseline for ZOMACTON versus GENOTROPIN.
5.To investigate the safety of treatment of ZOMACTON as compared to GENOTROPIN (safety lab, frequency and severity of adverse events, immunogenicity)
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Primary end point(s): 1. Height velocity based on the 12 months treatment period.
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Secondary ID(s)
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FE 999905 CS07
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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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