Drug Use Investigation of Somatropin for GHD-ADULTS. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00601419

Purpose

Post marketing drug use investigation of Genotropin for GHD-ADULTS.

Condition	Intervention	Phase
Dwarfism, Growth Hormone Deficiency	Drug: Somatropin	Phase IV

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism

Drug Information available for: Somatropin Somatotropin

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: 6 month ] [ Designated as safety issue: No ]
The incidence of adverse drug reactions. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

This study is a non-interventional/observational study and does not have any secondary outcomes measures. [ Time Frame: There are no secondary outcomes for this study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Somatropin Patients administered Somatropin.	Drug: Somatropin Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg. Dosage, Frequency: According to Japanese LPD, "The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day". Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration.

Groups/Cohorts

Assigned Interventions

Somatropin

Patients administered Somatropin.

Drug: Somatropin

Genotropin® 12mg for Injection, Genotropin® MiniQuick for s.c. injection 0.6mg, Genotropin® MiniQuick for s.c. injection 1.0mg, Genotropin® MiniQuick for s.c. injection 1.4mg, Genotropin® 5.3mg.

Dosage, Frequency: According to Japanese LPD, "The initial dosage is 0.021mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. The dosage is titrated by 0.084mg/kg/week at a maximum according to the patient's clinical symptoms, and administered in 6-7 divided doses in a week by s.c. route. The dosage may be adjusted according to patient's clinical symptoms and laboratory test results such as serum Insulin-like Growth Factor-I (IGF-I) concentrations. However, the maximum daily dosage shouldn't be higher than 1mg/day".

Duration: According to the protocol of A6281286, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 6 month after the first administration.

Eligibility

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

Study Population

The patients whom an investigator involving A6281286 prescribes the Somatropin.

Criteria

Inclusion Criteria:

The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".

Exclusion Criteria:

Patients not administered Somatropin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601419

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 by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS ONE. 2009 May 22;4(5):e5668.

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6281286
Study First Received:	January 15, 2008
Last Updated:	December 23, 2009
ClinicalTrials.gov Identifier:	NCT00601419 History of Changes
Health Authority:	Japan: Institutional Review Board

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 08, 2010