Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq (OPTIMA)

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234533
First received: October 5, 2005
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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
Turner Syndrome
Renal Insufficiency, Chronic
Pituitary Diseases
Dwarfism
Drug: Somatropin (rDNA origin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Number of capillary blood spot IGF-1 measurements and optimal timing of samples to assess the IGF-1 status of NutropinAq treated patients [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Factors affecting the variability of capillary IGF-1 measurements [ Time Frame: At day 0, 3 months, 5 months and 6 months after daily injections ] [ Designated as safety issue: No ]
  • Precision profile of capillary versus plasma IGF-1 measurements [ Time Frame: At day 0, 3 months and 6 months after daily injections ] [ Designated as safety issue: No ]
  • Auxological parameters during NutropinAq treatment [ Time Frame: After 3 months and 6 months of daily injections ] [ Designated as safety issue: No ]
  • Acceptability of the NutropinAq Pen [ Time Frame: After 5 months of daily injections ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: Somatropin (rDNA origin)
    Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children under 18 with growth failure associated with inadequate growth hormone secretion, or Turner syndrome or chronic renal insufficiency.

Exclusion Criteria:

  • Children with closed epiphyses
  • Children with active neoplasm
  • Children with acute critical illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234533

  Hide Study Locations
Locations
Belgium
Dienst Kindergeneeskunde
Brussels, Belgium, B-1090
Dienst Kindergeneeskunde
Edegem, Belgium, B-2650
Czech Republic
Klinika Deti a Dorostu
Praha, Czech Republic, 100 34
Denmark
Aalborg Sygehus Nord, Borneafdelingen
Aalborg, Denmark, 9100
Sygeh. i Ringkjobing Amt, Borneafdeling
Herning, Denmark, 7400
Finland
Helsinki University Central Hospital
Helsinki, Finland
France
CHU - Hôtel Dieu
Angers, France, 49033
Cabinet Médical
Bordeaux, France, 33000
CHU Grenoble
Grenoble, France, 38043
Centre Hospitalier General
Le Havre, France, 76083
CHU Timone Enfants
Marseille, France, 13385
CHU de Montpellier
Montpellier, France, 34295
Hôpital Archet 2
Nice, France, 06202
Hôpital Saint-Vincent de Paul
Paris, France, 75674
Groupe Hospitalier de Necker
Paris, France, 75743
Hôpital Charles Nicolle
Rouen, France, 76031
CHU Hautepierre
Strasbourg, France, 67100
Centre Hospitalier de Bigorre
Tarbes, France, 65013
Hôpital des Enfants
Toulouse, France, 31059
Cabinet Médical
Toulouse, France, 31000
Centre Pédiatrique Gatien de Clocheville
Tours, France, 37044
Germany
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04317
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Greece
PA Kyriakou Children's Hospital
Athens, Greece
General State Hospital of Nikaia
Athens, Greece, 18454
Italy
Azienda Policlinico - Università di Catania
Catania, Italy, 78-95123
Ospedale Policlinico
Chieti, Italy, 5-66013
Clinica Pediatrica II
Firenze, Italy, 13-50132
Clinica Pediatrica, Universita Federico II di Napoli
Napoli, Italy
Il Università degli Studi di Napoli
Napoli, Italy, 4-80138
Clinica Pediatrica
Novara, Italy, 18-28100
Clinica Pediatrica
Parma, Italy, 14-43100
Romania
Institutul de Endocrinologie C.I. Parhon
Bucuresti, Romania, Sector 1
Russian Federation
Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology
Moscow, Russian Federation
Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age
Moscow, Russian Federation
Slovakia
Il Detska Klinika
Limbova, Slovakia, 833 40
Spain
Hospital de Nens de Barcelona
Barcelona, Spain, 08009
Hospital General Universitario
Elche, Spain, 03203
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Parc Taulí
Sabadell, Spain, 08208
Hospital Clínico Universitario
Santiago de Compostela, Spain, 15706
Ukraine
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
United Kingdom
St George's Hospital
London, England, United Kingdom, SW17 0QT
University Hospital Wales
Cardiff, Wales, United Kingdom, 14 4XW
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Pascale Dutailly, MD Ipsen
  More Information

No publications provided

Responsible Party: Pascale Dutailly MD, Ipsen
ClinicalTrials.gov Identifier: NCT00234533     History of Changes
Other Study ID Numbers: 2-79-58035-700
Study First Received: October 5, 2005
Last Updated: May 14, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
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 of the Russian Federation
Finland: Finnish Medicines Agency
Ukraine: Ministry of Health

Keywords provided by Ipsen:
growth
child development
growth hormone
inadequate growth hormone secretion
growth failure

Additional relevant MeSH terms:
Dwarfism
Pituitary Diseases
Renal Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Renal Insufficiency, Chronic
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Kidney Diseases
Urologic Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders
Ovarian Diseases

ClinicalTrials.gov processed this record on July 20, 2014