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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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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2024 |
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Main ID: |
NCT00163189 |
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Date of registration:
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09/09/2005 |
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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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Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
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Scientific title:
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Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00163189 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Glucocorticosteroid treatment for 12 months at least
- Bone age < 15 years for a boy and < 13 years for a girl
- Child measured height < - 2 SD, Child currently treated by GH
Exclusion Criteria:
- Known diabetes (type 1 or type 2)
- A previous history of intolerance or hypersensitivity to the study drug or to drugs
with similar chemical structures
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Somatropin
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Primary Outcome(s)
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Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
[Time Frame: Baseline, Month 36]
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Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
[Time Frame: Baseline, Month 36]
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Secondary Outcome(s)
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Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)
[Time Frame: Month 12, 24, 36, 48, 60]
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Annual Growth Rate (AGR)
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60
[Time Frame: Baseline, Month 12, 24, 48, 60]
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Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Ratio of Bone Age (BA) to Chronological Age (CA)
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Mean Height
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Body Mass Index (BMI)
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Change From Baseline in Height at Month 12, 24, 36, 48 and 60
[Time Frame: Baseline, Month 12, 24, 36, 48, 60]
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Secondary ID(s)
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2004-002992-17
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A6281271
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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