Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Phase 4

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children

• Registration Number: NCT00567385
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03-10
• Primary Completion: 2004-03-22
• Study Completion: 2004-03-22
• Study First Submitted: 2007-11-30
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• Growth failure due to growth hormone insufficiency (GHD)
• Turner syndrome: established diagnosis according to sex chromosome analysis, or
• Growth retardation in children with chronic renal disorders

Exclusion Criteria

• Pregnancy
• Breast feeding women
• Suspected or know allergy to trial product
• Participating in any other trial involving other investigational products within the last 3 months
• Previous participation in the trial
• Other daily injection therapy (non-growth hormone, e.g insulin-therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of acceptance	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Safety
Adverse Events (AE)
Compliance

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Altunizade-Istanbul, Turkey