Long Term Use of Somatropin in Patients Small for Gestational Age - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00793325

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 IV

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

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

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: No ]
The incidence of adverse drug reactions in this surveillance. [ Time Frame: 3 years maximum ] [ Designated as safety issue: No ]
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 3 years maximum ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (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."

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."

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6281292
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00793325
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

ClinicalTrials.gov processed this record on January 15, 2009