NCT00567385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

November 30, 2007

Last Update Submit

February 27, 2017

Conditions

Growth Hormone DisorderGrowth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (1)

  • Assessment of acceptance

    after 12 weeks of treatment

Secondary Outcomes (3)

  • Safety

  • Adverse Events (AE)

  • Compliance

Interventions

somatropinDRUG

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Altunizade-Istanbul, 34662, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

March 10, 2003

Primary Completion

March 22, 2004

Study Completion

March 22, 2004

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

TU(1)