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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00163215 |
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.
Condition | Intervention | Phase |
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Endocrine System Diseases |
Drug: Somatropin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study. |
Estimated Enrollment: | 60 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Somatropin: Experimental |
Drug: Somatropin
Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
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Ages Eligible for Study: | 11 Years to 13 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
France | |
Pfizer Investigational Site | Active, not recruiting |
PARIS, France, 75743 | |
Pfizer Investigational Site | Active, not recruiting |
Besancon, France, 25030 | |
Pfizer Investigational Site | Recruiting |
Paris, France, 75019 | |
Pfizer Investigational Site | Active, not recruiting |
Grenoble Cedex, France, 38043 | |
Pfizer Investigational Site | Active, not recruiting |
Bordeaux, France, 33000 | |
Pfizer Investigational Site | Active, not recruiting |
Bordeaux, France, 33076 | |
Pfizer Investigational Site | Completed |
Annemasse Cedex, France, 74107 | |
Pfizer Investigational Site | Active, not recruiting |
Annecy, France, 74011 | |
Pfizer Investigational Site | Active, not recruiting |
BRON CEDEX, France, 69677 | |
Pfizer Investigational Site | Recruiting |
Marseille, France, 13385 | |
Pfizer Investigational Site | Recruiting |
Toulouse Cedex, France, 31026 | |
Pfizer Investigational Site | Active, not recruiting |
Lyon Cedex 05, France, 69322 | |
Pfizer Investigational Site | Recruiting |
Montpellier, France, 34059 | |
Pfizer Investigational Site | Active, not recruiting |
VANDOEUVRE LES NANCY CEDEX, France, 54511 | |
Pfizer Investigational Site | Active, not recruiting |
Dijon, France, 21000 | |
Pfizer Investigational Site | Not yet recruiting |
CLERMONT-FERRAND, France, 63058 | |
Pfizer Investigational Site | Recruiting |
Lorient, France, 56100 | |
Pfizer Investigational Site | Active, not recruiting |
Paris, France, 75674 Cedex | |
Pfizer Investigational Site | Active, not recruiting |
Paris, France, 75571 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6281269 |
Study First Received: | September 9, 2005 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00163215 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Endocrine System Diseases Endocrinopathy |
Endocrine System Diseases |