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

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

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

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 identifier: NCT00234533

  Show 45 Study Locations
Sponsors and Collaborators
Study Director: Pascale Dutailly, MD Ipsen
  More Information

Responsible Party: Pascale Dutailly MD, Ipsen 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:
child development
growth hormone
inadequate growth hormone secretion
growth failure

Additional relevant MeSH terms:
Gonadal Dysgenesis
Pituitary Diseases
Primary Ovarian Insufficiency
Renal Insufficiency
Renal Insufficiency, Chronic
Turner Syndrome
Adnexal Diseases
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Hypothalamic Diseases
Kidney Diseases
Nervous System Diseases
Ovarian Diseases
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Urologic Diseases processed this record on May 02, 2016