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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: January 10, 2013
Last verified: January 2013
History of Changes
  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 Phase
Small for Gestational Age
 Drug: Somatropin
 Phase 4

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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00793325     History of Changes
Other Study ID Numbers: A6281292
Study First Received: November 17, 2008
Last Updated: January 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

ClinicalTrials.gov processed this record on May 22, 2013