NCT01518036

Brief Summary

This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 1987

Longer than P75 for phase_3

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

September 14, 1987

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2004

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

16.6 years

First QC Date

January 20, 2012

Last Update Submit

February 27, 2017

Conditions

Genetic DisorderTurner Syndrome

Outcome Measures

Primary Outcomes (1)

  • Final height in cm

Secondary Outcomes (3)

  • Ratio between change in bone age and change in chronological age

  • Age at onset of puberty

  • Adverse events

Study Arms (2)

Low dose

EXPERIMENTAL
Drug: somatropin

High dose

EXPERIMENTAL
Drug: somatropin

Interventions

somatropinDRUG

2.9 IU/m\^2/day. Administered as once daily subcutaneous injection until final height is reached

Low dose

Eligibility Criteria

Age2 Years - 11 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Turner Syndrome
  • Not previously treated with growth hormone or androgen
  • Well-documented height over the previous 12 months
  • Informed consent of parents (and child if appropriate)

You may not qualify if:

  • Growth hormone (GH) deficiency based on a GH stimulation test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Genetic Diseases, InbornTurner Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesSex Chromosome DisordersChromosome DisordersGonadal DisordersEndocrine System Diseases

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 25, 2012

Study Start

September 14, 1987

Primary Completion

April 11, 2004

Study Completion

April 11, 2004

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

GB(1)