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

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NCT01073605

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Study Location
Pfizer Investigational Site
Amiens, , 80030, France
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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

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Growth Disorders, Intrauterine Growth RetardationGenotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
NCT01073605
  1. Amiens,
  2. Angers cedex,
  3. Besancon Cedex,
  4. Bordeaux Cedex,
  5. Bordeaux,
  6. Boulogne,
  7. Brest,
  8. Bron Cedex,
  9. Clermont Ferrand,
  10. Dijon,
  11. Grenoble,
  12. Hyères,
  13. Lille,
  14. Lille,
  15. Marseille cedex 5,
  16. Montpellier,
  17. Nantes Cedex 1,
  18. Nice,
  19. Paris,
  20. Paris,
  21. Paris,
  22. Reims,
  23. Rennes,
  24. Rouen,
  25. Saint Priest en Jarez,
  26. Strasbourg Cedex 2,
  27. Tarbes,
  28. Toulouse Cedex,
  29. Tours,
  30. Vandoeuvre Les Nancy Cedex,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
Official Title  ICMJE A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation
Brief Summary To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Disorders
  • Intrauterine Growth Retardation
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2010)		208
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01073605
Other Study ID Numbers  ICMJE 93-8122-001
A6281186, CTN 93-8122-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP