Drug Use Investigation of Somatropin for GHD-ADULTS.

Completed

• Conditions: Dwarfism, Growth Hormone Deficiency
• Interventions: Drug: Somatropin

• Registration Number: NCT00601419
• Lead Sponsor: Pfizer

Brief Summary

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

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-01-28
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-17
• Results First Submitted QC: 2013-12-17
• Last Update Submitted: 2013-12-17
• Results First Posted: 2014-02-06
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

Patients not administered Somatropin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatropin	Somatropin	Patients administered Somatropin.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.	6 month	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.	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.
Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	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.
Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.	6 month	To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.
Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.	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.
Proportion of Participants Achieving Clinical Efficacy by Gender.	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.
Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.	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.
Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.	6 month	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.	6 month	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 by Initial Dose of Somatropin.	6 month	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.	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.