Long Term Use of Somatropin in Patients Small for Gestational Age

Completed

• Conditions: Small for Gestational Age
• Interventions: Drug: Somatropin

• Registration Number: NCT00793325
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-19
• Study Start: 2009-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2013-12-17
• Last Update Submitted: 2013-12-17
• Results First Posted: 2014-02-06
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

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

Exclusion Criteria

• Patients not administered Somatropin (Genotropin®).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatropin	Somatropin	Patients administered Somatropin.

Primary Outcome Measures

Name	Time	Method
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	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.
Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.	Up to 3 years	To determine whether age is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.	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.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.	Up to 3 years	To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).	Up to 3 years	To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.	Up to 3 years	To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.	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.
Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.	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.
Number of Participants With Treatment Related Adverse Events.	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.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications	Up to 3 years	To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.	Up to 3 years	To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.
Change in Height SD Score for Calendar Age.	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.