Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sandoz Identifier:
First received: October 1, 2007
Last updated: September 24, 2014
Last verified: September 2014

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Condition Intervention Phase
Small for Gestational Age
Drug: Somatropin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • The primary objective of this study is to evaluate the long-term effect of growth hormone treatment on the development of diabetes during the treatment period in short children born SGA. [ Time Frame: Patients discontinues treatment when final height is reached. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • •to report the incidence of anti-rhGH AB´s and of E. coli host cell peptide AB´s during Omnitrope® treatment •to evaluate the efficacy of Omnitrope® treatment in SGA, IGF-I and IGFBP-3 levels during treatment and incidence and severity of adverse events [ Time Frame: Patients discontinues treatment when final height is reached. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: October 2007
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single-arm non-comparative somatropin safety study (PASS)
Drug: Somatropin
Infant, Small for Gestational Age, Omnitrope®/Somatropin, rhGH,


Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Pre-pubertal (Tanner stage I) children born SGA

    • Boys: 4 years of age or older
    • Girls: 4 years of age or older
  2. Growth disturbance for chronological age and sex according to country specific references
  3. Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria:

  1. Onset of puberty
  2. Closed epiphyses
  3. Diabetes mellitus type I or type II
  4. Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
  5. Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
  6. Acute critical illness
  7. Previous treatment with any hGH preparation
  8. Treatment with antidiabetic medication (e.g. metformin, insulin)
  9. Drug abuse, substance abuse, or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00537914

Czech Republic
Prague, Czech Republic
Tiblisi, Georgia
Munich, Germany
Budapest, Hungary
Szczencin, Poland
Bucharest, Romania
Sponsors and Collaborators
Study Chair: Sandoz Biopharmaceuticals Sandoz
  More Information

No publications provided

Responsible Party: Sandoz Identifier: NCT00537914     History of Changes
Other Study ID Numbers: EP00-401
Study First Received: October 1, 2007
Last Updated: September 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Georgia: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Romania: Ministry of Public Health
Romania: National Medicines Agency

Keywords provided by Sandoz:
Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA processed this record on March 03, 2015