Drug Use Investigation of Somatropin for GHD-ADULTS.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00601419
First received: January 15, 2008
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Dwarfism, Growth Hormone Deficiency
Drug: Somatropin
Phase 4

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

Resource links provided by NLM:


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 ]

Enrollment: 230
Study Start Date: March 2007
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® 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.


Detailed Description:

All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.

  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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00601419     History of Changes
Other Study ID Numbers: A6281286
Study First Received: January 15, 2008
Last Updated: January 2, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013