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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01529944
First received: January 2, 2012
Last updated: April 29, 2014
Last verified: April 2014
  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
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:


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 ] [ 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
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

Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: 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: April 29, 2014
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 July 26, 2014