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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Last updated on August 9, 2018

FOR MORE INFORMATION
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.
Show details

- 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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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
The 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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Brain Injuries
  • Growth Hormone Deficiency
  • 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.
  • Experimental: Genotropin treatment arm
    Not Specified
    Intervention: Drug: Genotropin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
 
 
NCT00555009
A6281289
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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