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These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling.
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Drug Details
| Pfizer Inc. |
|
Genotropin |
somatropin |
NCT00638053 | Growth Hormone Deficiency |
Phase IV |
http://www.pfizer.com/pfizer/download/uspi_genotropin.pdf (For additional Approved Drug Labels, see "Details") |
Protocol No. GENGHD-0018-078: Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study To Evaluate The Effects Of Genotropin In Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma And/Or Head Injury.
The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.
Link to ClinicalTrials.gov registration: http://www.clinicaltrials.gov/ct2/show/NCT00638053?term=GENGHD-0018-078&rank=1
http://www.pfizer.com/pfizer/download/usi_genotropin_miniquick.pdf
http://www.pfizer.com/pfizer/download/usi_genotropin_mixer.pdf
http://www.pfizer.com/pfizer/download/usi_genotropin_pen5.pdf
http://www.pfizer.com/pfizer/download/usi_genotropin_pen12.pdf
Pfizer will use reasonable efforts to include accurate and up-to-date information on the ClinicalStudyResults.org web site. However, because the status of studies often changes, Pfizer can make no, and makes no, warranties or representations of any kind as to the currency or completeness of the information contained therein. You agree that access to and use of information posted by Pfizer on the ClinicalStudyResults.org web site is at your own risk. Pfizer disclaims all warranties, express or implied, including warranties of merchantability of fitness for a particular purpose. Pfizer shall not be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of, or inability to use information posted by Pfizer on the ClinicalStudyResults.org web site, or any errors or omissions in the content thereof. The ClinicalStudyResults.org web site is maintained by PhRMA, a trade association of which Pfizer is a member. PhRMA had no role in the sponsorship or conduct of the studies posted by Pfizer on ClinicalStudyResults.org. |
| Protocol No. GENGHD-0018-078 |  | |
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