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: December 17, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Dwarfism, Growth Hormone Deficiency
Drug: Somatropin

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:
  • Number of Participants With Treatment Related Adverse Events. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.

  • Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.

  • Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    To determine whether age is a significant risk factor in the frequency of treatment related adverse events.

  • Number of Participants With Treatment Related Adverse Events of Somatropin by Gender. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.

  • Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.

  • Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

  • Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.

  • Proportion of Participants Achieving Clinical Efficacy. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.

  • Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.

  • Proportion of Participants Achieving Clinical Efficacy by Gender. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.

  • Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Number of participants achieving clinical efficacy / Number of evaluable participants. Clinical efficacy was assessed comprehensively by physicians in three categories, 'effective', 'not effective', and 'not evaluable', based on the time profile of variables.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: December 17, 2013
Last Updated: December 17, 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 July 24, 2014