Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
NCT00174421
Last updated date
ABOUT THIS STUDY
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult)
height in short children born small for gestational age
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 Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Participation in the 90-080 study
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Any severe, acute or chronic disease
- Any other identifiable reason for short stature
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Growth DisorderTreatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
NCT00174421
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height | |||
| Official Title ICMJE | Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium | |||
| Brief Summary | This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Growth Disorder | |||
| Intervention ICMJE | Drug: Treatment with Genotropin in different dosages | |||
| 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 | 36 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | August 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00174421 | |||
| Other Study ID Numbers ICMJE | 98-8122-011 A6281219 | |||
| 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 | ||||