Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
NCT00174408
Last updated date
ABOUT THIS STUDY
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in
short children born SGA. Safety of the drug is a main objective as well. The growth promoting
effect of two different dosages is compared. The effect of long-term treatment on final
height is evaluated (according to several amendments)
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
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Disorders
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
3-7 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Birth length below -2 SD
- Height at start below - 2 Sd
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Any endocrine or chronic disease
- Any known syndrome with short stature
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Growth DisordersTreatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
NCT00174408
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age | |||
| Official Title ICMJE | Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm) | |||
| Brief Summary | The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments) | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Growth Disorders | |||
| Intervention ICMJE | Drug: Genotropin | |||
| Study Arms ICMJE | Not Provided | |||
| 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 | |||
| Enrollment ICMJE | 110 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | February 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 3 Years to 7 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00174408 | |||
| Other Study ID Numbers ICMJE | 89-041 A6281048 | |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | May 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||