Post marketing drug use investigation of Genotropin for GHD-ADULTS.
The patients who were administered Somatropin to treat "Adult growth hormone deficiency
(limited to severe type)".
Patients not administered Somatropin.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Drug Use Investigation of Somatropin for GHD-ADULTS. | |||
| Official Title | Drug Use Investigation of GENOTROPIN for GHD-ADULTS. | |||
| Brief Summary | Post marketing drug use investigation of Genotropin for GHD-ADULTS. | |||
| 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 | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involving A6281286 prescribes the Somatropin. | |||
| Condition | Dwarfism, Growth Hormone Deficiency | |||
| 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. | |||
| Study Groups/Cohorts | Somatropin Patients administered Somatropin. Intervention: Drug: Somatropin | |||
| 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. | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 230 | |||
| Original Estimated Enrollment | 200 | |||
| Actual Study Completion Date | December 2012 | |||
| Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility 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. | |||
| Sex/Gender |
| |||
| Ages | Child, Adult, Older Adult | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00601419 | |||
| Other Study ID Numbers | A6281286 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2013 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
