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

Primary Purpose

Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
somatropin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Somatropin

Arm Description

Outcomes

Primary Outcome Measures

Patient acceptance of the new liquid growth hormone formulation

Secondary Outcome Measures

Number of Adverse Events (AE)
Number of Serious Adverse Events (SAE)

Full Information

First Posted
March 23, 2012
Last Updated
February 23, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01563926
Brief Title
Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
Official Title
An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 23, 2000 (Actual)
Primary Completion Date
October 10, 2002 (Actual)
Study Completion Date
October 10, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Somatropin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)
Primary Outcome Measure Information:
Title
Patient acceptance of the new liquid growth hormone formulation
Secondary Outcome Measure Information:
Title
Number of Adverse Events (AE)
Title
Number of Serious Adverse Events (SAE)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Petah Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel - Aviv
ZIP/Postal Code
64293
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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