Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
NCT00174252
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- Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
- Measured Height < -2.5 Standard Deviation
- Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2
(Tanner)
- Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic
insufficiency, neoplasia)
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Descriptive Information | ||||
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Brief Title ICMJE | Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age | |||
Official Title ICMJE | Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation. | |||
Brief Summary | To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation 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 | Fetal Growth Retardation | |||
Intervention ICMJE | Drug: Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years | |||
Study Arms ICMJE | Experimental: Genotonorm (Somatropin)
Intervention: Drug: Genotonorm (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 | 57 | |||
Original Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 4 Years to 9 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 | NCT00174252 | |||
Other Study ID Numbers ICMJE | A6281234 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |