Drug Use Investigation of Somatropin for GHD-ADULTS.

Dwarfism, Growth Hormone Deficiency Clinical Trial

Official title:

Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601419
• Other study ID #: A6281286
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: December 17, 2013
• Start date: March 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Growth Hormone Deficiency
• Dwarfism, Pituitary

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Related Adverse Events.	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.	6 month	Yes
Primary	Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.	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.	6 month	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.	To determine whether age is a significant risk factor in the frequency of treatment related adverse events.	6 month	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.	To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.	6 month	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.	To determine whether TSH deficiency is a significant risk factor in the frequency of treatment related adverse events.	6 month	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.	To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.	6 month	Yes
Primary	Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.	To determine whether initial dose of somatropin is a significant risk factor in the frequency of treatment related adverse events.	6 month	Yes
Primary	Proportion of Participants Achieving Clinical Efficacy.	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.	6 month	No
Primary	Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.	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.	6 month	No
Primary	Proportion of Participants Achieving Clinical Efficacy by Gender.	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.	6 month	No
Primary	Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.	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.	6 month	No

External Links

•   To obtain contact information for a study center near you, click here.