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Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

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NCT01073605

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Amiens, , 80030 France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Disorders, Intrauterine Growth Retardation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronological age (CA) between 3 and 10 for girls

- Chronological age between 3 and 12 for boys

- Height for CA below - 2 SD

- Birth length for CA below -2SD

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Endocrine disease except well-substituted hypothyroidism

- Sever chronic disease

- Skeletal dysplasia

- Known chromosomal aberration

- Ongoing treatment with steroids

- Known intrauterine infection

NCT01073605
Pfizer
Completed
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

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[email protected]

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Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Disorders
  • Intrauterine Growth Retardation
  • Drug: Genotonorm
    0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
  • Drug: Genotonorm
    1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
  • Drug: Genotonorm
    1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
  • Active Comparator: Genotonorm A
    Continuous 0.7 IU/kg/week or 0.03 mg/kg/day
    Intervention: Drug: Genotonorm
  • Active Comparator: Genotonorm B
    Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day
    Intervention: Drug: Genotonorm
  • Active Comparator: Genotonorm C
    Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
    Intervention: Drug: Genotonorm
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronological age (CA) between 3 and 10 for girls
  • Chronological age between 3 and 12 for boys
  • Height for CA below - 2 SD
  • Birth length for CA below -2SD

Exclusion Criteria:

  • Endocrine disease except well-substituted hypothyroidism
  • Sever chronic disease
  • Skeletal dysplasia
  • Known chromosomal aberration
  • Ongoing treatment with steroids
  • Known intrauterine infection
Sexes Eligible for Study: All
3 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01073605
93-8122-001
A6281186, CTN 93-8122-001
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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