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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01529840
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 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.


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

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) from start of treatment to final height (referenced to normal population) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Final height SDS [ Designated as safety issue: No ]
  • Change in height SDS from start of treatment to final height (referenced to Noonan population) [ Designated as safety issue: No ]
  • Height velocity [ Designated as safety issue: No ]
  • Change in height velocity [ Designated as safety issue: No ]
  • Sitting height [ Designated as safety issue: No ]
  • Number and proportion of subjects with final height SDS above -2 SDS [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose 33 mcg/kg/day 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
Experimental: High dose 66 mcg/kg/day 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01529840

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: NCT01529840     History of Changes
Other Study ID Numbers: GHNOO-1658, 2005-000042-37
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 August 28, 2014