This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
- Participation in the 90-080 study
- Any severe, acute or chronic disease
- Any other identifiable reason for short stature
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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:
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| Sex/Gender ICMJE |
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| 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 |
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| 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 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
