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Drug Use Investigation of Somatropin for GHD-ADULTS.

Last updated on November 9, 2019

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Study Location
Contact
1-800-718-1021
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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Descriptive Information
Brief TitleDrug Use Investigation of Somatropin for GHD-ADULTS.
Official TitleDrug Use Investigation of GENOTROPIN for GHD-ADULTS.
Brief SummaryPost marketing drug use investigation of Genotropin for GHD-ADULTS.
Detailed DescriptionAll the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationThe patients whom an investigator involving A6281286 prescribes the Somatropin.
ConditionDwarfism, Growth Hormone Deficiency
InterventionDrug: 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/CohortsSomatropin
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 StatusCompleted
Actual Enrollment
 (submitted: January 2, 2013)
230
Original Estimated Enrollment
 (submitted: January 25, 2008)
200
Actual Study Completion DateDecember 2012
Actual Primary Completion DateDecember 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
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00601419
Other Study ID NumbersA6281286
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2013

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