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Completed

NCT Number: NCT01529944

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

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.

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Key information

Conditions

Genetic Disorder Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Noonan Syndrome Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gothenburg, 416 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation

Treatment and study plan

Somatropin

Drug

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.

Primary outcomes

  1. Change in height SDS (Standard Deviation Score) (referenced to normal population)

    Time frame: From baseline until final height is reached

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 9, 2012
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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