Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

NCT00174252

Last updated date
Study Location
Pfizer Investigational Site
Amiens, , 80030, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fetal Growth Retardation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-9 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.

- Measured Height < -2.5 Standard Deviation

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


- Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2
(Tanner)


- Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic
insufficiency, neoplasia)

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Fetal Growth RetardationStudy Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age NCT00174252
  1. Amiens,
  2. ANGERS Cedex 03,
  3. Besançon,
  4. Bordeaux,
  5. Bron Cedex,
  6. Caen Cedex 5,
  7. Dunkerque Cedex 1,
  8. Lille,
  9. Limoges Cedex,
  10. Lorient,
  11. Nice,
  12. PARIS Cedex 19,
  13. Paris,
  14. Paris,
  15. Rennes,
  16. Rouen,
  17. Strasbourg,
  18. Tarbes,
  19. Toulouse,
  20. Toulouse,
  21. Tours,
  22. Vandoeuvre Les Nancy,
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Official Title  ICMJE Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.
Brief Summary To estimate the percentage of children with serum IGF-1 > 2 standard deviation (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fetal Growth Retardation
Intervention  ICMJE Drug: Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
Study Arms  ICMJE Experimental: Genotonorm (Somatropin)
Intervention: Drug: Genotonorm (Somatropin)
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: June 26, 2009)
57
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
100
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl.
  • Measured Height < -2.5 Standard Deviation

Exclusion Criteria:

  • Pubertal signs ie: testis volume > or = 4 ml in boys and breast stage > or = B2 (Tanner)
  • Serious chronic disease (diabetes, renal insufficiency, heart failure, hepatic insufficiency, neoplasia)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 4 Years to 9 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 NCT00174252
Other Study ID Numbers  ICMJE A6281234
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 June 2009

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