- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529840
Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
January 17, 2017 updated by: Novo Nordisk A/S
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Göteborg, Sweden, 416 85
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low dose 33 mcg/kg/day
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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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
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Secondary Outcome Measures
Outcome Measure |
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Adverse events
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Height velocity
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Final height SDS
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Change in height SDS from start of treatment to final height (referenced to Noonan population)
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Change in height velocity
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Sitting height
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Number and proportion of subjects with final height SDS above -2 SDS
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 1990
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
January 2, 2012
First Submitted That Met QC Criteria
February 8, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Disease
- Congenital Abnormalities
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Syndrome
- Genetic Diseases, Inborn
- Noonan Syndrome
Other Study ID Numbers
- GHNOO-1658
- 2005-000042-37 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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