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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

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.

Condition or disease Intervention/treatment Phase
Genetic Disorder Noonan Syndrome Drug: somatropin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
Study Start Date : June 1990
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Low dose 33 mcg/kg/day 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
Experimental: High dose 66 mcg/kg/day 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



Primary Outcome Measures :
  1. Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)

Secondary Outcome Measures :
  1. Final height SDS
  2. Change in height SDS from start of treatment to final height (referenced to Noonan population)
  3. Height velocity
  4. Change in height velocity
  5. Sitting height
  6. Number and proportion of subjects with final height SDS above -2 SDS
  7. Adverse events


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529840


Locations
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01529840     History of Changes
Other Study ID Numbers: GHNOO-1658
2005-000042-37 ( EudraCT Number )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Noonan Syndrome
Syndrome
Genetic Diseases, Inborn
Disease
Pathologic Processes
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases