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Drug Use Investigation of Somatropin for GHD-ADULTS.

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ClinicalTrials.gov Identifier: NCT00601419
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Dwarfism, Growth Hormone Deficiency Drug: Somatropin

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

Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
Study Start Date : March 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Participants With Treatment Related Adverse Events. [ Time Frame: 6 month ]
    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.

  2. Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. [ Time Frame: 6 month ]
    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.

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

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

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

  6. 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 ]
    To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

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

  8. Proportion of Participants Achieving Clinical Efficacy. [ Time Frame: 6 month ]
    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.

  9. Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age. [ Time Frame: 6 month ]
    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.

  10. Proportion of Participants Achieving Clinical Efficacy by Gender. [ Time Frame: 6 month ]
    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.

  11. Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency. [ Time Frame: 6 month ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601419


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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
First Posted: January 28, 2008    Key Record Dates
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014
Last Verified: December 2013

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