Drug Use Investigation of Somatropin for GHD-ADULTS.
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Purpose
Post marketing drug use investigation of Genotropin for GHD-ADULTS.
| Condition | Intervention | Phase |
|---|---|---|
|
Dwarfism, Growth Hormone Deficiency |
Drug: Somatropin |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Drug Use Investigation of GENOTROPIN for GHD-ADULTS. |
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- The incidence of adverse drug reactions. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- The number of adverse drug reactions not expected from the LPD (unknown adverse drug reactions). [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- This study is a non-interventional/observational study and does not have any secondary outcomes measures. [ Time Frame: There are no secondary outcomes for this study ] [ Designated as safety issue: No ]
| Enrollment: | 230 |
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patients whom an investigator involving A6281286 prescribes the Somatropin.
Inclusion Criteria:
The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".
Exclusion Criteria:
Patients not administered Somatropin.
Contacts and Locations More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00601419 History of Changes |
| Other Study ID Numbers: | A6281286 |
| Study First Received: | January 15, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Japan: Institutional Review Board |
Additional relevant MeSH terms:
|
Dwarfism Dwarfism, Pituitary Endocrine System Diseases Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn |
Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013