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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Creteil Cedex, , 94010 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain Injuries, Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Have had a previous traumatic brain injury (more than 1 year and less than 20 years)
prior to the screening visit.

- Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

- Have proven GHD deficiency

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

- Active systemic malignancy or active intracranial tumor. A successfully treated tumor
or malignancy is not an exclusion criterion if the patient has not had active disease
for 5 years and is not currently receiving maintenance chemotherapy, (except for
basal cell skin cancers.

- Receiving treatment with prednisolone in doses above 10 mg/day or treatment with
other oral glucocorticosteroids above replacement doses is not permitted throughout
the study. Topical and inhaled corticosteroids are permitted.

- History of dementia unrelated to TBI

- History of benign intracranial hypertension

NCT00555009
Pfizer
Terminated
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

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Descriptive Information
Brief Title  ICMJE Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Official Title  ICMJE Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
Brief SummaryTo establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
Detailed DescriptionThe study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain Injuries
  • Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: Genotropin
    Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
  • Drug: Placebo
    Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.
Study Arms  ICMJE
  • Experimental: Genotropin treatment arm
    Not Specified
    Intervention: Drug: Genotropin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 6, 2009)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2007)
120
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion DateJanuary 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.
  • Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
  • Have proven GHD deficiency

Exclusion Criteria:

  • Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
  • Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.
  • History of dementia unrelated to TBI
  • History of benign intracranial hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00555009
Other Study ID Numbers  ICMJE A6281289
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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