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Drug Use Investigation of Somatropin for GHD-ADULTS.

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NCT00601419

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency Dwarfism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Patients not administered Somatropin.

NCT00601419
Pfizer
Completed
Drug Use Investigation of Somatropin for GHD-ADULTS.

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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.
All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
The patients whom an investigator involving A6281286 prescribes the Somatropin.
Dwarfism, Growth Hormone Deficiency
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.
Somatropin
Patients administered Somatropin.
Intervention: Drug: Somatropin
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.
 
Completed
230
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Patients not administered Somatropin.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00601419
A6281286
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

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