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Growth Retardation In Children With Special Pathological Conditions Or Disease

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Annemasse Cedex, , 74107 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endocrine System Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-13 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Bone age

- Naive child: Measured Height

- Child currently treated by GH

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

- Idiopathic short stature

- Syndrome known to be associated with an increased risk of cancer e.g. family history
of adenomatous polyposis

NCT00163215
Pfizer
Completed
Growth Retardation In Children With Special Pathological Conditions Or Disease

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Growth Retardation In Children With Special Pathological Conditions Or Disease
Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.
To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endocrine System Diseases
Drug: Somatropin
Adapted dosage based on IGF 1 level and weight Form: liquid; Dosage and Frequency: from 0.0033mg/kg/day to 0.0067 mg/kg/day; Duration: 3 years
Experimental: Somatropin
Intervention: Drug: Somatropin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bone age < 13 years for a boy and < 11 years for a girl
  • Naive child: Measured Height < -2.5 SD for CA
  • Child currently treated by GH

Exclusion Criteria:

  • Idiopathic short stature
  • Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis
Sexes Eligible for Study: All
11 Years to 13 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00163215
A6281269
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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