Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
NCT01859949
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Adult Trials: 18+ Years
Children with short stature due to SGA who received treatment in the study GENASG-0021-002.
- Children who have any chronic disease requiring treatment with steroid hormone that
may affect growth promotion including estrogen, androgen, anabolic hormone, and
corticosteroids (except those for external use), and have received the treatment.
- Children who have received radiotherapy or chemotherapy.
- Children who have serious cardiac disease, renal disease, or hepatic disease.
- Children who have diabetes mellitus with a manifestation of abnormal glucose
metabolism.
- Children who have serious chronic disease.
- Children who have malignant tumor.
- Children who are allergic to m-cresol.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA) | |||
| Official Title ICMJE | Long Term Study Of Pnu-180307 For Short Children Born Small For Gestational Age (Sga) Without Epiphyseal Closure (Extension Of The Study 307-met-0021-002) | |||
| Brief Summary | To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Short Stature Born Small for Gestational Age (SGA) | |||
| Intervention ICMJE | Drug: Genotropin (somatropin)
Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients | |||
| Study Arms ICMJE | Experimental: Genotropin (somatropin)
Intervention: Drug: Genotropin (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 | 62 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2015 | |||
| Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria: Children with short stature due to SGA who received treatment in the study GENASG-0021-002. Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 4 Years to 8 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01859949 | |||
| Other Study ID Numbers ICMJE | GENASG-0021-007 A6281225 ( Other Identifier: Alias Study Number ) 2015-004552-21 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | No | |||
| 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 | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||