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Completed

NCT Number: NCT01897766

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

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).

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Key information

Conditions

Small For Gestational Age (SGA)

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A patient who was administered Somatropin (Genotropin).

Exclusion criteria

  • N/A.

Treatment and study plan

Somatropin

Drug

0.23 mg to 0.48 mg/kg/week

Other names: Genotropin

Primary outcomes

  1. Number of Participants With Adverse Drug Reaction (ADR)

    Time frame: Approximately 11.58 years

    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.

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

    Time frame: Baseline, Year 1

    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.

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

    Time frame: Baseline, Year 2

    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.

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

    Time frame: Baseline, Year 3

    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.

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

    Time frame: Baseline, Year 4

    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.

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

    Time frame: Baseline, Year 5

    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.

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

    Time frame: Baseline, Year 6

    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.

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

    Time frame: Baseline, Year 7

    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.

  9. Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

    Time frame: Baseline, Year 10

    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.

  10. Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1

    Time frame: Baseline, Year 1

    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.

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

    Time frame: Baseline, Year 2

    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.

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

    Time frame: Baseline, Year 3

    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.

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

    Time frame: Baseline, Year 4

    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.

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

    Time frame: Baseline, Year 5

    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.

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

    Time frame: Baseline, Year 6

    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.

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

    Time frame: Baseline, Year 7

    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.

  17. Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9

    Time frame: Baseline, Year 9

    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.

  18. Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

    Time frame: Baseline, Year 10

    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

  1. 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

    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.

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2013
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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