Study to Define Optimal IGF-1 Monitoring in Children Treated With NutropinAq - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00234533

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: pseudoachondroplasia Turner syndrome

MedlinePlus related topics: Dwarfism Pituitary Disorders Turner Syndrome

Drug Information available for: Somatropin Somatotropin

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:

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:	Ipsen ( Pascale Dutailly MD )
Study ID Numbers:	2-79-58035-700
Study First Received:	October 5, 2005
Last Updated:	May 14, 2009
ClinicalTrials.gov Identifier:	NCT00234533 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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 and Social Development 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
Renal Insufficiency
Gonadal Disorders
Brain Diseases
Bone Diseases
Sex Differentiation Disorders
Pathologic Processes
Urogenital Abnormalities
Urologic Diseases
Musculoskeletal Diseases
Syndrome
Bone Diseases, Developmental
Kidney Diseases

Congenital Abnormalities
Hypothalamic Diseases
Disease
Pituitary Diseases
Nervous System Diseases
Chromosome Disorders
Endocrine System Diseases
Central Nervous System Diseases
Turner Syndrome
Genetic Diseases, Inborn
Renal Insufficiency, Chronic
Sex Chromosome Disorders
Gonadal Dysgenesis

ClinicalTrials.gov processed this record on February 08, 2010