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Trial record 73 of 9085 for:    Genetic Diseases, Inborn AND genetic disorder

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

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ClinicalTrials.gov Identifier: NCT01529840
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 2, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE June 1990
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01529840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • Final height SDS
  • Change in height SDS from start of treatment to final height (referenced to Noonan population)
  • Height velocity
  • Change in height velocity
  • Sitting height
  • Number and proportion of subjects with final height SDS above -2 SDS
  • Adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
Official Title  ICMJE Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Genetic Disorder
  • Noonan Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Low dose 33 mcg/kg/day
    Intervention: Drug: somatropin
  • Experimental: High dose 66 mcg/kg/day
    Intervention: Drug: somatropin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date September 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01529840
Other Study ID Numbers  ICMJE GHNOO-1658
2005-000042-37 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP