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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 November 11, 2019
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FOR MORE INFORMATION
Study Location
University of Occupational and Environmental Health Hospital
Kita-Kyushu, Fukuoka, 807-8555 Japan
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Contact
1-800-718-1021
[email protected]
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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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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 SummaryTo assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
 (submitted: May 20, 2013)		62
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion DateAugust 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2016

ICMJE     Data element required by the

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

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