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Completed

NCT Number: NCT01529840

Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome

This trial is conducted in Europe. The aim of this trial is to evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.

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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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

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 original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial

Treatment and study plan

Somatropin

Drug

Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit

Primary outcomes

  1. Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)

Secondary outcomes

  1. Final height SDS

  2. Change in height SDS from start of treatment to final height (referenced to Noonan population)

  3. Height velocity

  4. Change in height velocity

  5. Sitting height

  6. Number and proportion of subjects with final height SDS above -2 SDS

  7. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

Important dates

Study start
1990
Primary completion
2005
Study completion
2005
First posted
Feb 9, 2012
Registry last updated
Jan 18, 2017

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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