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Long Term Use of Somatropin in Patients Small for Gestational Age

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small for Gestational Age

Intervention: Somatropin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Number of Participants With Treatment Related Adverse Events.

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

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

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

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

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

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

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

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

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

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

Change in Height SD Score for Calendar Age.

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in

the surveillance. Exclusion Criteria:

- Patients not administered Somatropin (Genotropin®).

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2009
Last updated: December 17, 2013

Page last updated: August 23, 2015

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