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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00625872 |
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
Condition | Intervention | Phase |
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Growth Hormone Therapy Infant, Small for Gestational Age |
Drug: Somatropin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial |
Estimated Enrollment: | 88 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment Group: Active Comparator
Somatropin for 12 months
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Drug: Somatropin
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
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Control Group
In the first 6 months no intervention, afterwards Somatropin for 12 months
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Drug: Somatropin
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
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Ages Eligible for Study: | 6 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Germany | |
Pfizer Investigational Site | Not yet recruiting |
Koeln, Germany, 50937 | |
Pfizer Investigational Site | Not yet recruiting |
Tuebingen, Germany, 72076 | |
Pfizer Investigational Site | Recruiting |
Erlangen, Germany, 91054 | |
Pfizer Investigational Site | Recruiting |
Muenchen, Germany, 80337 | |
Pfizer Investigational Site | Not yet recruiting |
Heidelberg, Germany, 69120 | |
Pfizer Investigational Site | Not yet recruiting |
Essen, Germany, 45122 | |
Pfizer Investigational Site | Not yet recruiting |
Freiburg, Germany, 79106 | |
Pfizer Investigational Site | Recruiting |
Datteln, Germany, 45711 | |
Pfizer Investigational Site | Not yet recruiting |
Bochum, Germany, 44866 | |
Pfizer Investigational Site | Not yet recruiting |
Dresden, Germany, 01307 | |
Pfizer Investigational Site | Recruiting |
Kiel, Germany, 24105 | |
Pfizer Investigational Site | Not yet recruiting |
Berlin, Germany, 13353 | |
Pfizer Investigational Site | Not yet recruiting |
Magdeburg, Germany, 39120 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6281283 |
Study First Received: | February 19, 2008 |
Last Updated: | December 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00625872 |
Health Authority: | Germany: Federal Institute for Drugs and Medicinal Devices (BfArM) |