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Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

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NCT00174291

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Paris, , 75019 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.
Endocrine System Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-14 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- This study will be proposed to all patients previously included in study CTN
97-8129-016

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

- Discontinuation of corticosteroid therapy for more than a year during study CTN
97-8129-016

- Patients withdrawing from the study prematurely

NCT00174291
Pfizer
Terminated
Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

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Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy
Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm (Registered) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy. Extension of the Study Beyond Three Years
  • To evaluate the effect of increasing the growth hormone dose on the statural response
  • To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endocrine System Diseases
Drug: Somatropin
Liquid, daily to final height Maximum Dosage: 50 µg/kg/day
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.
 
Terminated
21
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • This study will be proposed to all patients previously included in study CTN 97-8129-016

Exclusion Criteria:

  • Discontinuation of corticosteroid therapy for more than a year during study CTN 97-8129-016
  • Patients withdrawing from the study prematurely
Sexes Eligible for Study: All
4 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00174291
307-MET-9002-052
A6281024
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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