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

Overview

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.

Full Title of Study: “Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height – Data Collection and Follow-up Visit”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2005

Interventions

  • Drug: somatropin
    • 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
  • Drug: somatropin
    • 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

Arms, Groups and Cohorts

  • Experimental: Low dose 33 mcg/kg/day
  • Experimental: High dose 66 mcg/kg/day

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Final height SDS
  • Change in height SDS from start of treatment to final height (referenced to Noonan population)
  • Height velocity
  • Change in height velocity
  • Sitting height
  • Number and proportion of subjects with final height SDS above -2 SDS
  • Adverse events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Citations Reporting on Results

Osio D, Dahlgren J, Wikland KA, Westphal O. Improved final height with long-term growth hormone treatment in Noonan syndrome. Acta Paediatr. 2005 Sep;94(9):1232-7. doi: 10.1111/j.1651-2227.2005.tb02081.x.

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