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Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529944
First Posted: February 9, 2012
Last Update Posted: April 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.

Condition Intervention Phase
Genetic Disorder Noonan Syndrome Drug: somatropin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in height SDS (Standard Deviation Score) (referenced to normal population) [ Time Frame: From baseline until final height is reached ]

Secondary Outcome Measures:
  • Final height SDS (referenced to normal population) [ Time Frame: From baseline until final height is reached ]
  • Final height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ]
  • Change in height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ]
  • Number of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ]
  • Proportion of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ]
  • Adverse events [ Time Frame: From baseline until final height is reached ]

Enrollment: 22
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose 33 mcg/kg/day Drug: somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
Experimental: High dose 66 mcg/kg/day Drug: somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation
  Contacts and Locations
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): NCT01529944


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01529944     History of Changes
Other Study ID Numbers: GHNOO-3680
2008-004535-38 ( EudraCT Number )
First Submitted: January 2, 2012
First Posted: February 9, 2012
Last Update Posted: April 30, 2014
Last Verified: April 2014

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