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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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19 February 2015 |
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Main ID: |
NCT02205450 |
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Date of registration:
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30/07/2014 |
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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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Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell
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Scientific title:
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Experience With Growth Hormone (GH) in Children Under 2 Years With Prader-Willi Syndrome (PWS) in the Pediatric Endocrine Department of the Hospital of Sabadell |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02205450 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Raquel Corripio, MD PhD |
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Address:
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Telephone:
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+34937231010 |
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Email:
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rcorripio@tauli.cat |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children under 2 years
Exclusion Criteria:
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Age minimum:
N/A
Age maximum:
2 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Intervention(s)
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Drug: Recombinant Somatropin
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Primary Outcome(s)
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To assess the safe use of GH in children under 2 year old with Prader Willi Syndrome
[Time Frame: Two years]
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Secondary Outcome(s)
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Evaluate the impact of treatment with GH in kids under 2 years old on start walking
[Time Frame: Every 3 months during 2 years]
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Evaluate the impact of treatment with GH in kids under 2 years old on the speech beginning
[Time Frame: Every 3 months during 2 years]
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Evaluate the impact of treatment with GH in kids under 2 years old on body composition
[Time Frame: Every 3 months during 2 years]
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Secondary ID(s)
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CPT_ENDOPED201401
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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