Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
NCT ID: NCT00234533
Last Updated: 2019-12-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
251 participants
INTERVENTIONAL
2004-06-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NutropinAq 10 mg/2 mL (30 IU)
Patients received daily subcutaneous (s.c.) injections of NutropinAq 10 milligrams (mg)/2 milliliters (mL) for 6 months. The therapeutic daily doses administered were as follows:
* GHD patients: 0.025 - 0.035 mg/ kilogram (kg) bodyweight
* TS patients: up to 0.05 mg/kg bodyweight
* CRI patients: up to 0.05 mg/kg bodyweight
Patients visited the study clinic for a baseline visit and for 2 other visits every 3 months (Weeks 12 and 24). Additional home assessments were made at Weeks 21, 22 and 23.
The investigator determined the dose administered to each patient, and it was recommended to perform the injection in the evening.
Somatropin (rDNA origin)
Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Interventions
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Somatropin (rDNA origin)
Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children with active neoplasm
* Children with acute critical illness
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Dienst Kindergeneeskunde
Brussels, , Belgium
Dienst Kindergeneeskunde
Edegem, , Belgium
Klinika Deti a Dorostu
Prague, , Czechia
Aalborg Sygehus Nord, Borneafdelingen
Aalborg, , Denmark
Sygeh. i Ringkjobing Amt, Borneafdeling
Herning, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
CHU - Hôtel Dieu
Angers, , France
Cabinet Médical
Bordeaux, , France
CHU Grenoble
Grenoble, , France
Centre Hospitalier General
Le Havre, , France
CHU Timone Enfants
Marseille, , France
CHU de Montpellier
Montpellier, , France
Hôpital Archet 2
Nice, , France
Hôpital Saint-Vincent de Paul
Paris, , France
Groupe Hospitalier de Necker
Paris, , France
Hôpital Charles Nicolle
Rouen, , France
CHU Hautepierre
Strasbourg, , France
Centre Hospitalier de Bigorre
Tarbes, , France
Cabinet Médical
Toulouse, , France
Hôpital des Enfants
Toulouse, , France
Centre Pédiatrique Gatien de Clocheville
Tours, , France
Universitätsklinikum Leipzig AöR
Leipzig, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
General State Hospital of Nikaia
Athens, , Greece
PA Kyriakou Children's Hospital
Athens, , Greece
Azienda Policlinico - Università di Catania
Catania, , Italy
Ospedale Policlinico
Chieti, , Italy
Clinica Pediatrica II
Florence, , Italy
Il Università degli Studi di Napoli
Napoli, , Italy
Clinica Pediatrica, Universita Federico II di Napoli
Napoli, , Italy
Clinica Pediatrica
Novara, , Italy
Clinica Pediatrica
Parma, , Italy
Institutul de Endocrinologie C.I. Parhon
Bucharest, , Romania
Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology
Moscow, , Russia
Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age
Moscow, , Russia
Il Detska Klinika
Bratislava, , Slovakia
Hospital de Nens de Barcelona
Barcelona, , Spain
Hospital General Universitario
Elche, , Spain
Hospital Gregorio Marañón
Madrid, , Spain
Hospital Parc Taulí
Sabadell, , Spain
Hospital Clínico Universitario
Santiago de Compostela, , Spain
Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine
Kiev, , Ukraine
Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation
Kiev, , Ukraine
St George's Hospital
London, England, United Kingdom
University Hospital Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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2004-000356-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2-79-58035-700
Identifier Type: -
Identifier Source: org_study_id