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.

Study Overview

• Status: Completed
• Conditions: Short Stature Born Small for Gestational Age (SGA)
• Intervention / Treatment: Drug: Genotropin (somatropin)

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Month 12 (at the end of previous study) to 156

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height Velocity Standard Deviation Score (SDS) for Chronological Age	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.	Month 12 (at the end of previous study) to 156
Height Velocity	Height velocity is the yearly height gain	Month 12 (at the end of previous study) to 156
Height SDS for Chronological Age	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.	Month 12 (at the end of previous study) to 156
Height Velocity SDS for Bone Age	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.	Month 12 (at the end of previous study) to 156
Height SDS for Bone Age	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.	Month 12 (at the end of previous study) to 156

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2002
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Long-term; Short Stature; SGA; Genotropin(somatropin)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Dwarfism
• Other Study ID Numbers: GENASG-0021-007; A6281225 (Other Identifier: Alias Study Number); 2015-004552-21 (EudraCT Number)