Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

NCT01897766

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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
2-20 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A patient who was administered Somatropin (Genotropin).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- N/A.

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Small for Gestational Age (SGA)Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
NCT01897766
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Advanced Information
Descriptive Information
Brief Title Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Official Title AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
Brief Summary The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
Detailed Description All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  • A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (<or=-2 SD)).
  • A patient who is SGA and older than 3 years.
  • A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).
Condition Small for Gestational Age (SGA)
Intervention Drug: Somatropin
0.23 mg to 0.48 mg/kg/week
Other Name: Genotropin
Study Groups/Cohorts Somatropin
Patients administered Somatropin.
Intervention: Drug: Somatropin
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
 (submitted: January 29, 2020)
482
Original Estimated Enrollment
 (submitted: July 9, 2013)
500
Actual Study Completion Date June 7, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • A patient who was administered Somatropin (Genotropin).

Exclusion Criteria:

  • N/A.
Sex/Gender
Sexes Eligible for Study:All
Ages 2 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01897766
Other Study ID Numbers A6281314
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2020