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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537914
Recruitment Status : Active, not recruiting
First Posted : October 2, 2007
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Small for Gestational Age Drug: Somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2008
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
single-arm non-comparative somatropin safety study (PASS)
Drug: Somatropin
Infant, Small for Gestational Age, Omnitrope®/Somatropin, rhGH,

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. •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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00537914

Sandoz Investigative Site
Edegem, Belgium
Sandoz Investigative Site
Hradec Králové, Czechia
Sandoz Investigative Site
Prague, Czechia
Sandoz Investigational Site
Ústí nad Labem, Czechia
Sandoz Investigative Site
Tiblisi, Georgia
Sandoz Investigative Site
Munich, Germany
Sandoz Investigative Site
Sankt Augustin, Germany
Sandoz Investigative Site
Budapest, Hungary
Sandoz Investigative Site
Győr, Hungary
Sandoz Investigative Site
Miskolc, Hungary
Sandoz Investigative Site
Szeged, Hungary
Sandoz Investigative Site
Bydgoszcz, Poland
Sandoz Investigative Site
Gdańsk, Poland
Sandoz Investigative Site
Katowice, Poland
Sandoz Investigative Site
Kielce, Poland
Sandoz Investigative Site
Kraków, Poland
Sandoz Investigative Site
Lódz, Poland
Sandoz Investigative Site
Poznań, Poland
Sandoz Investigative Site
Rzeszów, Poland
Sandoz Investigative Site
Szczencin, Poland
Sandoz Investigative Site
Warszawa, Poland
Sandoz Investigative Site
Wroclaw, Poland
Sandoz Investigative Site
Wrocław, Poland
Sandoz Investigative Site
Zabrze, Poland
Sandoz Investigative Site
Bucharest, Romania
Sandoz Investigative Site
Cluj Napoca, Romania
Sandoz Investigative Site
Craiova, Romania
Sandoz Investigative Site
Iasi, Romania
Sandoz Investigative Site
Timisoara, Romania
Sponsors and Collaborators
Study Chair: Sandoz Biopharmaceuticals Sandoz GmbH

Responsible Party: Sandoz Identifier: NCT00537914     History of Changes
Other Study ID Numbers: EP00-401
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Sandoz:
Small for Gestational Age, Omnitrope®/Somatropin, rhGH,SGA