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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: |
EUCTR2004-005275-42-IT |
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Date of registration:
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23/01/2008 |
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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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Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis Imperfecta
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Scientific title:
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Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis Imperfecta |
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Date of first enrolment:
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21/03/2005 |
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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:2004-005275-42 |
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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: no
Open: no
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: 1 dei 2 farmaci dell'associazione sperimentale
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
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:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta
MedDRA version: 6.1
Level: SOC
Classification code 10010331
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Intervention(s)
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Trade Name: GENOTROPIN*1TBF 5,3MG (16UI)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.3-
Trade Name: NERIXIA*INFUS IV CONC 2F 100MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: VARI
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
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Primary Outcome(s)
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Main 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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