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

NCT00234533 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2019-12-09

Study results available
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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.

Conditions

  • Turner Syndrome
  • Renal Insufficiency, Chronic
  • Pituitary Diseases
  • Dwarfism

Interventions

DRUG

Somatropin (rDNA origin)

Daily subcutaneous injections, 0,025 - 0,05 mg/kg/day for 6 months.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00234533 on ClinicalTrials.gov