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

October 5, 2005
May 14, 2009
June 2004
July 2008   (final data collection date for primary outcome measure)
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 ]
Number of capillary blood spot IGF-1 measurements and optimal timing of samples to assess the IGF-1 status of NutropinAq treated patients.
Complete list of historical versions of study NCT00234533 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Factors affecting the variability of capillary IGF-1 measurements.
  • Precision profile of capillary versus plasma IGF-1 measurements.
  • Auxological parameters during NutropinAq treatment.
  • Acceptability of the NutropinAq Pen.
Not Provided
Not Provided
 
Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Turner Syndrome
  • Renal Insufficiency, Chronic
  • Pituitary Diseases
  • Dwarfism
Drug: Somatropin (rDNA origin)
Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Romania,   Russian Federation,   Slovakia,   Spain,   Ukraine,   United Kingdom
 
NCT00234533
2-79-58035-700
No
Pascale Dutailly MD, Ipsen
Ipsen
Not Provided
Study Director: Pascale Dutailly, MD Ipsen
Ipsen
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP