Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

NCT00174278

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

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

- All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014

- All patients who have stopped during one year will be included if a signed written informed consent

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


- Endocrine disease, except well substituted hypothyroidism


- Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

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Growth Hormone Deficiency, Growth RetardationTreatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
NCT00174278
  1. Paris,
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
Official Title  ICMJE Treatment With Recombinant Human Growth Hormone (Genotonorm®) 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 long-term treatment by Genotonorm on linear growth
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
  • Growth Hormone Deficiency
  • Growth Retardation
Intervention  ICMJE Drug: Somatropin
Study Arms  ICMJE Not Provided
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 Completed
Enrollment  ICMJE
 (submitted: September 9, 2005)
14
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
  • All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

  • Endocrine disease, except well substituted hypothyroidism
  • Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
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 NCT00174278
Other Study ID Numbers  ICMJE 96-8123-018
A6281217
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2008

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