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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
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 ]

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 ]
  • Precision profile of capillary versus plasma IGF-1 measurements [ Time Frame: At day 0, 3 months and 6 months after daily injections ]
  • Auxological parameters during NutropinAq treatment [ Time Frame: After 3 months and 6 months of daily injections ]
  • Acceptability of the NutropinAq Pen [ Time Frame: After 5 months of daily injections ]

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   (Child, Adult)
Sexes Eligible for Study:   All
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

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

Additional relevant MeSH terms:
Renal Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Renal Insufficiency, Chronic
Pituitary 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
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Developmental processed this record on April 21, 2017