Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT01897766Other idA6281314

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 482 participants (actual)
Sponsor: Pfizer · Industry
Design: Not stated
Countries: Not stated
Start: 5 Sept 2013
Primary completion: 28 Feb 2017
Completion: 7 Jun 2017
First posted: 12 Jul 2013 (estimated)
Last update posted: 25 Sept 2023
Conditions: Small for Gestational Age (SGA)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015201620172018

Ph –
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
NCT01897766
5 Sept 2013 to 7 Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

SomatropinDrug

Arms1

Other
Somatropin
Patients administered Somatropin.

Primary outcomes18

Outcomes the sponsor listed as primary.

Number of Participants With Adverse Drug Reaction (ADR)
Time frame · Approximately 11.58 years
Registry description
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1
Time frame · Baseline, Year 1
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time frame · Baseline, Year 2
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time frame · Baseline, Year 3
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time frame · Baseline, Year 4
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time frame · Baseline, Year 5
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time frame · Baseline, Year 6
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time frame · Baseline, Year 7
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time frame · Baseline, Year 10
Registry description
Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1
Time frame · Baseline, Year 1
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2
Time frame · Baseline, Year 2
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3
Time frame · Baseline, Year 3
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4
Time frame · Baseline, Year 4
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5
Time frame · Baseline, Year 5
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6
Time frame · Baseline, Year 6
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7
Time frame · Baseline, Year 7
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9
Time frame · Baseline, Year 9
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.
Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10
Time frame · Baseline, Year 10
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

Secondary outcomes(2)

Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height
Time frame · Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Registry description
Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.
Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline
Time frame · Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years
Registry description
Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Approximately 11.58 years

Number of Participants With Adverse Drug Reaction (ADR)

Group	Value (Participants)
Genotropin [Somatropin (Genetical Recombination)]	24

Primary outcomeMean· Baseline, Year 1

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	4.1	3.06

Primary outcomeMean· Baseline, Year 2

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	3.0	2.92

Primary outcomeMean· Baseline, Year 3

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	2.5	2.53

Primary outcomeMean· Baseline, Year 4

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	2.6	2.81

Primary outcomeMean· Baseline, Year 5

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	2.3	2.74

Primary outcomeMean· Baseline, Year 6

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	2.4	3.07

Primary outcomeMean· Baseline, Year 7

Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7

Group	Value (SD score)	Spread
Genotropin [Somatropin (Genetical Recombination)]	2.4	3.86

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Genotropin [Somatropin (Genetical Recombination)]Participants who received Genotropin treatment in a real world clinic setting as prescribed in clinical practice from July 2005 - February 2017. Data was observed retrospectively.	1 / 482	32 / 482	105 / 482

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 2 Years up to 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * A patient who was administered Somatropin (Genotropin). Exclusion Criteria: * N/A.

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