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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

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NCT00432263

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Brain Injuries
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 5 years)
prior to the screening visit.

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

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.

NCT00432263
Pfizer
Withdrawn
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 in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Brain Injuries
Drug: Genotropin (PN-180,307) Somatropin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

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

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00432263
A6281274
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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