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

NCT ID: NCT01859949

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2015-08-31

Brief Summary

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

Conditions

Short Stature Born Small for Gestational Age (SGA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genotropin (somatropin)

Group Type: EXPERIMENTAL

Genotropin (somatropin)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Occupational and Environmental Health Hospital

Kitakyushu, Fukuoka, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Hiroshima City Hospital

Hiroshima, Hiroshima, Japan

Asahikawa Medical University Hospital

Asahikawa, Hokkaido, Japan

Hokkaido Social Service Association Obihiro Hospital

Obihiro, Hokkaido, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Iwate Medical University Hospital

Morioka, Iwate, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Okayama University Hospital

Okayama, Okayama-ken, Japan

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi, Osaka, Japan

Osaka Employees' Pension Hospital

Osaka, Osaka, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Federal Officers' Mutual Aid Association Toranomon Hospital

Minato-ku, Tokyo, Japan

National Center for Child Health and Development

Setagaya-ku, Tokyo, Japan

Tottori University Hospital

Yonago, Tottori, Japan

Yamanashi University Hospital

Chūō, Yamanashi, Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=GENASG-0021-007&StudyName=Long%20Term%20Study%20of%20Genotropin%20%28Somatropin%29%20for%20Short%20Children%20Born%20Small%20for%20Gestational%20Age%20%28SGA%29

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

Other Identifiers

A6281225

Identifier Type: OTHER

Identifier Source: secondary_id

2015-004552-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GENASG-0021-007

Identifier Type: -

Identifier Source: org_study_id