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Drug Use Investigation of Somatropin for GHD-ADULTS.

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NCT00601419

Last updated on February 17, 2020
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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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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
 (submitted: January 2, 2013) 		230
Original Estimated Enrollment
 (submitted: January 25, 2008) 		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
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013

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1-800-718-1021

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