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Main
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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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18 April 2012 |
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Main ID: |
EUCTR2005-000384-26-IT |
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Date of registration:
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02/09/2005 |
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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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A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency
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Scientific title:
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A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency |
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Date of first enrolment:
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23/03/2006 |
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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:2005-000384-26 |
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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:
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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Czech Republic
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Germany
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Italy
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Email:
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Affiliation:
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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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
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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Growth hormone deficiency in adult
MedDRA version: 6.1
Level: PT
Classification code 10056438
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Intervention(s)
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Product Code: LB03002
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Somatropin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
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Primary Outcome(s)
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Secondary Objective:
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Main Objective:
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Primary end point(s):
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Secondary ID(s)
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BPLG-005
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2005-000384-26-ES
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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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