Growth Retardation In Children With Special Pathological Conditions Or Disease

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NCT00163215

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Study Location
Pfizer Investigational Site
Annemasse Cedex, , 74107, France
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[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
11-13 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Growth Retardation In Children With Special Pathological Conditions Or Disease
Official Title  ICMJE Evolution Of Growth Rate In Children Suffering From A Disease Associated With Growth Retardation and Treated By Genotonorm. A Pilot Study.
Brief Summary 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.
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 Endocrine System Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Somatropin
Intervention: Drug: Somatropin
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: October 12, 2011)		46
Original Enrollment  ICMJE
 (submitted: September 9, 2005)		60
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 11 Years to 13 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 NCT00163215
Other Study ID Numbers  ICMJE A6281269
Has Data Monitoring Committee Yes
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