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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 5, 2005

Last Updated Date

October 23, 2008

Start Date ^†

June 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00234533 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

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.

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Turner Syndrome
Renal Insufficiency, Chronic
Pituitary Diseases
Dwarfism

Intervention ^†

Drug: Somatropin (rDNA origin)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

250

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Romania, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00234533

Responsible Party

Pascale Dutailly MD, Ipsen

Secondary IDs ^††

Study Sponsor ^†

Ipsen

Collaborators ^††

Investigators ^†

Study Director:

Pascale Dutailly, MD

Ipsen

Information Provided By

Ipsen

Verification Date

October 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.