Clinical trial NCT00793325: Long Term Use of Somatropin in Patients Small for Gestational Age
Official title: Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small for Gestational Age
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 920
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).

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.

Eligibility 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®).

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events.
timeFrame: Up to 3 years
measure: Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.
timeFrame: Up to 3 years
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).
timeFrame: Up to 3 years
measure: Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.
timeFrame: Up to 3 years
measure: Change in Height SD Score for Calendar Age.
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: