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

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ClinicalTrials.gov Identifier: NCT01529944
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Genetic Disorder Noonan Syndrome Drug: somatropin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arms and Interventions
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Arm Intervention/treatment
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.


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

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

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

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation
Contacts and Locations
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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
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Sweden
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01529944    
Other Study ID Numbers: GHNOO-3680
2008-004535-38 ( EudraCT Number )
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: April 30, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Noonan Syndrome
Genetic Diseases, Inborn
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases