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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: January 17, 2017
Last verified: January 2017
  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
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)

Secondary Outcome 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

Enrollment: 24
Study Start Date: June 1990
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Sweden
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01529840     History of Changes
Other Study ID Numbers: GHNOO-1658
2005-000042-37 ( EudraCT Number )
Study First Received: January 2, 2012
Last Updated: January 17, 2017

Additional relevant MeSH terms:
Syndrome
Noonan Syndrome
Disease
Pathologic Processes
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 July 24, 2017