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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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01529944
First received: January 2, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  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
 Other: No treatment given
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Genetic Testing
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in height SDS (Standard Deviation Score) (referenced to normal population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final height SDS (referenced to normal population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Final height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Change in height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Number of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ] [ Designated as safety issue: No ]
  • Proportion of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]

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
No Intervention: Low dose 33 mcg/kg/day Other: No treatment given
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.
No Intervention: High dose 66 mcg/kg/day Other: No treatment given
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

Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529944

Locations
Sweden
Göteborg, Sweden, 416 85
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lene Finnerup Nielsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01529944     History of Changes
Other Study ID Numbers: GHNOO-3680, 2008-004535-38
Study First Received: January 2, 2012
Last Updated: July 10, 2012
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 21, 2013