Back to resultsTreatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
Primary Purpose
Growth Hormone Deficiency, Growth Retardation
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency
Eligibility Criteria
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)
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
The height measurements are always performed at the same time of the day by
use of a wallmounted device (e.g. Harpenden Stadiometer).
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
The body weight is measured by use of a balance scale.
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174278
Brief Title
Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the effect of long-term treatment by Genotonorm on linear growth
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency, Growth Retardation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Somatropin
Primary Outcome Measure Information:
Title
The main efficacy variable is the height SDS (SEMPE) before and after treatment.
Title
The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
Title
The height measurements are always performed at the same time of the day by
Title
use of a wallmounted device (e.g. Harpenden Stadiometer).
Title
Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
Title
The body weight is measured by use of a balance scale.
Title
Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Paris
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29029101
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96-8123-018&StudyName=Treatment+With+Recombinant+Human+Growth+Hormone+Genotonorm+%28Registered%29+In+Children+With+Short+Stature+Secondary+
Description
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Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
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