Growth Retardation In Children With Special Pathological Conditions Or Disease
NCT00163215
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- Bone age < 13 years for a boy and < 11 years for a girl
- Naive child: Measured Height < -2.5 SD for CA
- Child currently treated by GH
- Idiopathic short stature
- Syndrome known to be associated with an increased risk of cancer e.g. family history
of adenomatous polyposis
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Descriptive Information | ||||
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Brief Title ICMJE | Growth Retardation In Children With Special Pathological Conditions Or Disease | |||
Official Title ICMJE | Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study. | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Endocrine System Diseases | |||
Intervention ICMJE | 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 | |||
Study Arms ICMJE | Experimental: Somatropin
Intervention: Drug: Somatropin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 46 | |||
Original Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | October 2011 | |||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 11 Years to 13 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00163215 | |||
Other Study ID Numbers ICMJE | A6281269 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |