Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
NCT01897753
Last updated date
ABOUT THIS STUDY
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).
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.
Small For Gestational Age (SGA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
4 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- SGA children.
- Treated with GH at least 36 months.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients treated with GH for other indications (not SGA).
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Advanced Information
| 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||