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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234533
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : May 15, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Turner Syndrome Renal Insufficiency, Chronic Pituitary Diseases Dwarfism Drug: Somatropin (rDNA origin) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

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

Primary Outcome Measures :
  1. 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 :
  1. Factors affecting the variability of capillary IGF-1 measurements [ Time Frame: At day 0, 3 months, 5 months and 6 months after daily injections ]
  2. Precision profile of capillary versus plasma IGF-1 measurements [ Time Frame: At day 0, 3 months and 6 months after daily injections ]
  3. Auxological parameters during NutropinAq treatment [ Time Frame: After 3 months and 6 months of daily injections ]
  4. Acceptability of the NutropinAq Pen [ Time Frame: After 5 months of daily injections ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234533

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

Responsible Party: Pascale Dutailly MD, Ipsen Identifier: NCT00234533     History of Changes
Other Study ID Numbers: 2-79-58035-700
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 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
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Hypothalamic Diseases
Brain Diseases