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Completed

NCT Number: NCT00793325

Long Term Use of Somatropin in Patients Small for Gestational Age

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

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Key information

Conditions

Small for Gestational Age

Sex eligibility

All sexes

Study type

Observational

About this study

All the patients whom an investigator prescribes the first 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

  • Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

Exclusion criteria

  • Patients not administered Somatropin (Genotropin®).

Treatment and study plan

Somatropin

Drug

Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription.

Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."

Other names: Genotropin

Primary outcomes

  1. Number of Participants With Treatment Related Adverse Events.

    Time frame: Up to 3 years

    Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.

  2. Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

    Time frame: Up to 3 years

    Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.

  3. Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.

    Time frame: Up to 3 years

    To determine whether age is a significant risk factor in the frequency of treatment related adverse events.

  4. Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

    Time frame: Up to 3 years

    To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.

  5. Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.

    Time frame: Up to 3 years

    To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.

  6. Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.

    Time frame: Up to 3 years

    To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

  7. Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications

    Time frame: Up to 3 years

    To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.

  8. Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.

    Time frame: Up to 3 years

    To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.

  9. Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.

    Time frame: Up to 3 years

    To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.

  10. Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).

    Time frame: Up to 3 years

    To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.

  11. Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.

    Time frame: Up to 3 years

    Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). 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. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.

  12. Change in Height SD Score for Calendar Age.

    Time frame: Up to 3 years

    The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2008
Registry last updated
Feb 6, 2014

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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