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Long Term Use of Somatropin in Patients Small for Gestational Age
This study is enrolling participants by invitation only.
Study NCT00793325   Information provided by Pfizer
First Received: November 17, 2008   Last Updated: March 8, 2010   History of Changes

November 17, 2008
March 8, 2010
November 2008
October 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00793325 on ClinicalTrials.gov Archive Site
 
 
 
Long Term Use of Somatropin in Patients Small for Gestational Age
Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)

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.

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.

Phase IV
Observational
Case-Only, Prospective
Small for Gestational Age
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
Somatropin
Patients administered Somatropin.
Intervention: Drug: Somatropin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Enrolling by invitation
300
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

Exclusion Criteria:

  • Patients not administered Somatropin (Genotropin®).
Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00793325
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A6281292
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP