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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01518036
Other study ID # GHTUR/BPD/1
Secondary ID
Status Completed
Phase Phase 3
First received January 20, 2012
Last updated February 27, 2017
Start date September 14, 1987
Est. completion date April 11, 2004

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date April 11, 2004
Est. primary completion date April 11, 2004
Accepts healthy volunteers No
Gender Female
Age group 2 Years to 11 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

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

Study Design


Intervention

Drug:
somatropin
2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
somatropin
4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached

Locations

Country Name City State
United Kingdom Novo Nordisk Investigational Site Crawley

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Final height in cm
Secondary Ratio between change in bone age and change in chronological age
Secondary Age at onset of puberty
Secondary Adverse events
See also
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