The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).
- SGA children.
- Treated with GH at least 36 months.
- Patients treated with GH for other indications (not SGA).
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age | |||
| Official Title | Retrospective Study Of The Influence Of Age At Start Of Growth Hormone (Gh) Treatment On Height Gain In Children Born Small for Gestational Age (SGA) | |||
| Brief Summary | The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA). | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | SGA children treated with GH at least 36 months | |||
| Condition | Small For Gestational Age (SGA) | |||
| Intervention | Drug: growth hormone 36 months | |||
| Study Groups/Cohorts | Small For Gestational Age (SGA) Children SGA children under growth hormone treatment for more than 36 months. Intervention: Drug: growth hormone | |||
| 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 | Completed | |||
| Actual Enrollment | 264 | |||
| Original Estimated Enrollment | 300 | |||
| Actual Study Completion Date | September 2013 | |||
| Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 4 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Spain | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01897753 | |||
| Other Study ID Numbers | A6281310 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||
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
