Drug Use Investigation of Somatropin for GHD-ADULTS.

Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

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

Study Overview

• Status: Completed
• Conditions: Dwarfism, Growth Hormone Deficiency
• Intervention / Treatment: 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
• Enrollment (Actual): 230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6281286 prescribes the Somatropin.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS One. 2009 May 22;4(5):e5668. doi: 10.1371/journal.pone.0005668.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 15, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): January 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Dwarfism
• Other Study ID Numbers: A6281286