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Trial record 1 of 1 for:    A6281225
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Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

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ClinicalTrials.gov Identifier: NCT01859949
Recruitment Status : Completed
First Posted : May 22, 2013
Results First Posted : March 15, 2016
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Condition or disease Intervention/treatment Phase
Short Stature Born Small for Gestational Age (SGA) Drug: Genotropin (somatropin) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2002
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Genotropin (somatropin) 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



Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Month 12 (at the end of previous study) to 156 ]

Secondary Outcome Measures :
  1. Height Velocity Standard Deviation Score (SDS) for Chronological Age [ Time Frame: Month 12 (at the end of previous study) to 156 ]

    Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,

    where mean and standard deviation were based on standard Japanese values of the participants age and gender.

    The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.


  2. Height Velocity [ Time Frame: Month 12 (at the end of previous study) to 156 ]
    Height velocity is the yearly height gain

  3. Height SDS for Chronological Age [ Time Frame: Month 12 (at the end of previous study) to 156 ]

    Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,

    where mean and standard deviation were based on standard Japanese values on the participant age and gender.

    The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.


  4. Height Velocity SDS for Bone Age [ Time Frame: Month 12 (at the end of previous study) to 156 ]

    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.

    Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,

    where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.

    The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.


  5. Height SDS for Bone Age [ Time Frame: Month 12 (at the end of previous study) to 156 ]

    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.

    Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,

    where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.

    The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.




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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859949


Locations
Japan
University of Occupational and Environmental Health Hospital
Kita-Kyushu, Fukuoka, Japan, 807-8555
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan, 078-8510
Hokkaido Social Service Association Obihiro Hospital
Obihiro, Hokkaido, Japan, 080-0805
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
Kitasato University Hospital
Sagamihara, Kanagawa, Japan, 252-0375
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan, 594-1101
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan, 430-8558
Federal Officers' Mutual Aid Association Toranomon Hospital
Minato-ku, Tokyo, Japan, 105-8470
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan, 157-8535
Tottori University Hospital
Yonago, Tottori, Japan, 683-8504
Yamanashi University Hospital
Chuo, Yamanashi, Japan, 409-3898
Hiroshima City Hospital
Hiroshima, Japan, 730-8518
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kyoto University Hospital
Kyoto, Japan, 606-8507
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka Employees' Pension Hospital
Osaka, Japan, 553-0003
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01859949     History of Changes
Other Study ID Numbers: GENASG-0021-007
A6281225 ( Other Identifier: Alias Study Number )
2015-004552-21 ( EudraCT Number )
First Posted: May 22, 2013    Key Record Dates
Results First Posted: March 15, 2016
Last Update Posted: May 3, 2016
Last Verified: March 2016

Keywords provided by Pfizer:
Genotropin(somatropin)
SGA
Short Stature
Long-term
Safety

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases