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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small for Gestational Age

Intervention: Somatropin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Sandoz

Official(s) and/or principal investigator(s):
Sandoz Biopharmaceuticals, Study Chair, Affiliation: Sandoz

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).

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: •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

Eligibility

Minimum age: 4 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Sandoz Investigative Site, Edegem, Belgium

Sandoz Investigative Site, Hradec Králové, Czech Republic

Sandoz Investigative Site, Prague, Czech Republic

Sandoz Investigational Site, Ústí nad Labem, Czech Republic

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

Additional Information

Starting date: October 2007
Last updated: March 11, 2015

Page last updated: August 23, 2015

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