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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00234533 |
The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.
Condition | Intervention | Phase |
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Turner Syndrome Renal Insufficiency, Chronic Pituitary Diseases Dwarfism |
Drug: Somatropin (rDNA origin) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method |
Estimated Enrollment: | 250 |
Study Start Date: | June 2004 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pascale Dutailly, MD | Ipsen |
Responsible Party: | Ipsen ( Pascale Dutailly MD ) |
Study ID Numbers: | 2-79-58035-700 |
Study First Received: | October 5, 2005 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00234533 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Italy: Ministry of Health; Belgium: Directorate general for the protection of Public health: Medicines; Spain: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; Lithuania: State Medicine Control Agency - Ministry of Health; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; Denmark: Danish Medicines Agency; Austria: Federal Ministry for Health and Women; Russia: Ministry of Health and Social Development of the Russian Federation; Finland: National Agency for Medicines; Ukraine: Ministry of Health |
growth child development growth hormone inadequate growth hormone secretion growth failure |
Chromosomal abnormalities Dwarfism Renal Insufficiency Genital dwarfism Gonadal Disorders Brain Diseases Bone Diseases Sex Differentiation Disorders Gonadal dysgenesis Urogenital Abnormalities Musculoskeletal Diseases Urologic Diseases Bone Diseases, Developmental Kidney Diseases |
Congenital Abnormalities Hypothalamic Diseases Pituitary Diseases Chromosome Disorders Central Nervous System Diseases Endocrine System Diseases Monosomy X Turner Syndrome Genetic Diseases, Inborn Renal Insufficiency, Chronic Turner syndrome Ovarian dwarfism Endocrinopathy Gonadal Dysgenesis |
Pathologic Processes Disease Syndrome Nervous System Diseases Sex Chromosome Disorders |