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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT01529840 (opens ClinicalTrials.gov in a new tab)Other idGHNOO-1658Other id2005-000042-37Other id2005
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Overview

Status
Completed
Phase
Phase 3
Enrollment
24 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Sweden

Start
Jun 1990
Primary completion
Sept 2005
Completion
Sept 2005
First posted
9 Feb 2012 (estimated)
Last update posted
18 Jan 2017 (estimated)
Conditions
Genetic Disorder · Noonan Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1990199520002005
  1. Ph 3

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

    NCT01529840

    Jun 1990 to Sept 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somatropinDrug
  • somatropinDrug

Arms2

  • Experimental

    Low dose 33 mcg/kg/day

  • Experimental

    High dose 66 mcg/kg/day

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(7)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2005

6 results

Improved final height with long-term growth hormone treatment in Noonan syndrome.

Osio et al. 2005Acta paediatrica (Oslo, Norway : 1992)cited by 57

PMID 16203673DOI 10.1111/j.1651-2227.2005.tb02081.xPUB-16203673

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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