Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Phase 3

Completed

• Conditions: Turner Syndrome; Growth Hormone Disorder; Growth Hormone Deficiency in Children; Genetic Disorder
• Interventions: Drug: somatropin

• Registration Number: NCT01563926
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10-23
• Primary Completion: 2002-10-10
• Study Completion: 2002-10-10
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-24
• Study First Posted: 2012-03-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Written Informed Consent by patient and/or guardian/parents
• Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
• Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
• Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Patient acceptance of the new liquid growth hormone formulation

Secondary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events (SAE)
Number of Adverse Events (AE)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇱 Tel - Aviv, Israel