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

Last updated on December 16, 2017

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

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)

NCT00174252
Pfizer
Completed
Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age

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Study Aimed At Improving Height With Genotonorm In Children Born Little And/Or Light With Growth Retardation At The Age
Evolution of IGF-1 in Children Born Small for Gestational Age and With Growth Retardation, Treated by Genotonorm Especially Evolution After Dose Adaptation.
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fetal Growth Retardation
Drug: Genotonorm (Somatropin)
0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years
Experimental: Genotonorm (Somatropin)
Intervention: Drug: Genotonorm (Somatropin)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
April 2009
April 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
4 Years to 9 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00174252
A6281234
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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