Long Term Use of Somatropin in Patients Small for Gestational Age

Small for Gestational Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00793325
• Other study ID #: A6281292
• Status: Completed
• Phase: N/A
• First received: November 17, 2008
• Last updated: December 17, 2013
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Small for Gestational Age

Intervention

Drug:
• Somatropin
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."

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Related Adverse Events.	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.	Up to 3 years	Yes
Primary	Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	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.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.	To determine whether age is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.	To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.	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.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.	To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications	To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.	To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.	To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).	To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.	Up to 3 years	Yes
Primary	Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.	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.	Up to 3 years	No
Primary	Change in Height SD Score for Calendar Age.	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.	Up to 3 years	No

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