Clinical trial NCT01897766: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small for Gestational Age (SGA)
Keywords: Genotropin
Somatropin
Long Term Follow-Up
Special Investigation
Small for Gestational Age
SGA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 482
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* A patient who was administered Somatropin (Genotropin).

Exclusion Criteria:

* N/A.

Primary outcomes:
measure: Number of Participants With Adverse Drug Reaction (ADR)
timeFrame: Approximately 11.58 years
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
timeFrame: Baseline, Year 1
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
timeFrame: Baseline, Year 2
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
timeFrame: Baseline, Year 3
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
timeFrame: Baseline, Year 4
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
timeFrame: Baseline, Year 5
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
timeFrame: Baseline, Year 6
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
timeFrame: Baseline, Year 7
measure: Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
timeFrame: Baseline, Year 10
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
timeFrame: Baseline, Year 1
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
timeFrame: Baseline, Year 2
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
timeFrame: Baseline, Year 3
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
timeFrame: Baseline, Year 4
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
timeFrame: Baseline, Year 5
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
timeFrame: Baseline, Year 6
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
timeFrame: Baseline, Year 7
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
timeFrame: Baseline, Year 9
measure: Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
timeFrame: Baseline, Year 10
Secondary outcomes:
measure: Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
timeFrame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
measure: Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
timeFrame: Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: