Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height

NCT00396474

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

- Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years

- Untreated SGA (based on birth weight and/or length below -2 standard deviations [SDs] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:

- Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or

- Subjects born SGA with short stature (height SDs > 1.3 below target at final height).

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


- Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2


- Familial dyslipidemia

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ALL GENDERS
19 Months+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
Official Title Long-Term Metabolic Risk In Small for Gestational Age (SGA) Patients After Growth Hormone Treatment Compared To Matched, Untreated Controls
Brief Summary The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass index (BMI) who are not treated with growth hormone (GH) and who remain short at final height.
Detailed Description case-control
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood, serum
Sampling Method Probability Sample
Study Population SGA Subjects treated or untreated with growth hormone
Condition Infant, Small for Gestational Age
Intervention Other: post GH treatment observational study
Intravenous glucose tolerance test (IVGTT)
Study Groups/Cohorts SGA patients
Infants born small for SGA who either received GH, no GH, or growth within normal ranges.
Intervention: Other: post GH treatment observational study
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 Withdrawn
Actual Enrollment
 (submitted: April 21, 2015)
0
Original Enrollment
 (submitted: November 6, 2006)
90
Estimated Study Completion Date January 2012
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Patients with SGA treated with growth hormone in one of the following Genotropin studies (89-041, 89-070/071, 90-079, 90-080/98-8122-011) for at least 3 years and after having stopped GH treatment for 5-10 years
  • Untreated SGA (based on birth weight and/or length below -2 standard deviations [SDs] for gestational age) matched to treated SGA by body mass index (+ or = 10%) and gender:

    • Subjects born SGA with normal final height (within +/- 1.3 SD of their target height); or
    • Subjects born SGA with short stature (height SDs > 1.3 below target at final height).

Exclusion Criteria:

  • Known diabetes type 1 or 2, or 1st degree relative of a patient with diabetes type 2
  • Familial dyslipidemia
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00396474
Other Study ID Numbers A6281279
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2015