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Completed

NCT Number: NCT01859949

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

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

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Key information

Conditions

Short Stature Born Small for Gestational Age (SGA) Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Musculoskeletal Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Occupational and Environmental Health Hospital, Kitakyushu, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genotropin (somatropin)

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2015
Study completion
2015
First posted
May 22, 2013
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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