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Completed

NCT Number: NCT00601419

Drug Use Investigation of Somatropin for GHD-ADULTS.

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

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Key information

Conditions

Dwarfism, Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients not administered Somatropin.

Treatment and study plan

Somatropin

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Drug Use Investigation of GENOTROPIN for GHD-ADULTS.

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jan 28, 2008
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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