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Trial record 1 of 1 for:    NCT01897766
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Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age (SGA)

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ClinicalTrials.gov Identifier: NCT01897766
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 9, 2013
First Posted Date July 12, 2013
Last Update Posted Date April 19, 2017
Actual Study Start Date September 2013
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2013)
  • Change in growth rate SD score for calendar age [ Time Frame: 6 years maximum ]
  • Change in height SD score for calendar age [ Time Frame: 6 years maximum ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01897766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 9, 2013)
Final height [ Time Frame: 6 years maximum ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age (SGA)
Official Title Special Investigation For Genotropin(Sga Long Follow-up)
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
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: April 17, 2017)
488
Original Estimated Enrollment
 (submitted: July 9, 2013)
500
Actual Study Completion Date February 2017
Actual Primary Completion Date February 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 up 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 Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2017