NCT01731028

Brief Summary

The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

4.9 years

First QC Date

November 16, 2012

Last Update Submit

January 31, 2013

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Zomacton® treatment measured by the increase in body height per annuum

    5 years

Secondary Outcomes (2)

  • Efficacy of Zomacton® treatment measured by the increase in body weight per annuum

    5 years

  • Safety of Zomacton® and the application device measured by local adverse reactions to the application device

    5 years

Study Arms (1)

Somatropin

Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization

Drug: Somatropin

Interventions

SomatropinDRUG

Somatropin powder and solvent for solution for injection

Somatropin

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome

You may qualify if:

  • therapeutic need according to the approved specific products characteristics (SPC)

You may not qualify if:

  • contraindication according to the SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 21, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

February 1, 2013

Record last verified: 2013-01