Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

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NCT00174187

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Study Location
Pfizer Investigational Site
Paris, , 75019, France
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Contact
1-800-718-1021
[email protected]
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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
11-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children with juvenile arthritis or nephrotic syndrome

- Before or during puberty

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


- Diabetes Type 1 and 2


- Endocrine disease, except well substituted hypothyroidism

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Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy
Official Title  ICMJE Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.
Brief Summary
  • To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
  • To assess the effect of a long term treatment with Genotonorm on bone mineralisation
  • To assess the effect of a long term treatment with Genotonorm on body composition
Detailed Description 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.
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 Endocrine System Diseases
Intervention  ICMJE Drug: Somatropin
liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day
Study Arms  ICMJE Experimental: Somatropin
Intervention: Drug: Somatropin
Publications * David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 9, 2005)		30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with juvenile arthritis or nephrotic syndrome
  • Before or during puberty

Exclusion Criteria:

  • Diabetes Type 1 and 2
  • Endocrine disease, except well substituted hypothyroidism
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 11 Years to 17 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 NCT00174187
Other Study ID Numbers  ICMJE 307-MET-9002-0009
A6281016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2012

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