Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174421
First received: September 12, 2005
Last updated: May 1, 2007
Last verified: May 2007
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Purpose
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Disorder |
Drug: Treatment with Genotropin in different dosages |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium |
Resource links provided by NLM:
Genetics Home Reference related topics:
Meier-Gorlin syndrome
metatropic dysplasia
pseudoachondroplasia
MedlinePlus related topics:
Growth Disorders
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Final height, compared to the expected familial target height
Secondary Outcome Measures:
- Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | August 2005 |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participation in the 90-080 study
Exclusion Criteria:
- Any severe, acute or chronic disease
- Any other identifiable reason for short stature
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174421
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174421
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00174421 History of Changes |
| Other Study ID Numbers: | 98-8122-011 A6281219 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 1, 2007 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Growth Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016