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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
History of Changes
  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:

Drug Information available for: Somatropin
U.S. FDA Resources

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

  Show 45 Study Locations
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: 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 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 May 23, 2013