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Drug Use Investigation of Somatropin for GHD-ADULTS.

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dwarfism, Growth Hormone Deficiency

Intervention: Somatropin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

Number of Participants With Treatment Related Adverse Events.

Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.

Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.

Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.

Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.

Proportion of Participants Achieving Clinical Efficacy.

Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.

Proportion of Participants Achieving Clinical Efficacy by Gender.

Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

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

Starting date: March 2007
Last updated: December 17, 2013

Page last updated: August 23, 2015

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