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Long Term Use of Somatropin in Patients Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793325
First received: November 17, 2008
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Small for Gestational Age
Drug: Somatropin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment Related Adverse Events. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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 Unlisted Treatment Related Adverse Events According to Japanese Package Insert. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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 by Gender. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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 Complications vs. Without Complications [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    To determine whether hepatic function disorder 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. [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.

  • Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.

  • Change in Height SD Score for Calendar Age. [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 920
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin
Patients administered Somatropin.
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."

Other Name: Genotropin

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).

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®).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793325

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00793325     History of Changes
Other Study ID Numbers: A6281292
Study First Received: November 17, 2008
Results First Received: December 17, 2013
Last Updated: December 17, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

ClinicalTrials.gov processed this record on November 23, 2014