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NCT01529840 Clinical Trial

Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome

Genetic Disorder Clinical Trial

Official title:
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01529840
Other study ID # GHNOO-1658
Secondary ID 2005-000042-37
Status Completed
Phase Phase 3
First received January 2, 2012
Last updated January 17, 2017
Start date June 1990
Est. completion date September 2005

Study information
Verified date January 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 evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date September 2005
Est. primary completion date September 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit
• somatropin
Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit

Locations
Country Name City State
Sweden Novo Nordisk Investigational Site Göteborg

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Osio D, Dahlgren J, Wikland KA, Westphal O. Improved final height with long-term growth hormone treatment in Noonan syndrome. Acta Paediatr. 2005 Sep;94(9):1232-7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary Final height SDS
Secondary Change in height SDS from start of treatment to final height (referenced to Noonan population)
Secondary Height velocity
Secondary Change in height velocity
Secondary Sitting height
Secondary Number and proportion of subjects with final height SDS above -2 SDS
Secondary Adverse events
See also
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Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
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Completed NCT01604161 - Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome N/A
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Completed NCT01710696 - Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome Phase 3
Completed NCT01401244 - Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers Phase 1

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