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Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

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NCT01859949

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
University of Occupational and Environmental Health Hospital
Kita-Kyushu, Fukuoka, 807-8555 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Short Stature Born Small for Gestational Age (SGA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-8 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01859949
Pfizer
Completed
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

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Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
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)
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Short Stature Born Small for Gestational Age (SGA)
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
Experimental: Genotropin (somatropin)
Intervention: Drug: Genotropin (somatropin)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Children with short stature due to SGA who received treatment in the study GENASG-0021-002.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
4 Years to 8 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01859949
GENASG-0021-007
A6281225 ( Other Identifier: Alias Study Number )
2015-004552-21 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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