| October 24, 2007 |
| March 6, 2009 |
| March 2008 |
| January 2009 (final data collection date for primary outcome measure) |
| The primary endpoint is the change from baseline in the CogState™ composite score. [ Time Frame: At Week 36 ] [ Designated as safety issue: No ] |
| The primary endpoint is the change from baseline in the CogState composite score. [ Time Frame: At Week 36 ] |
| Complete list of historical versions of study NCT00555009 on ClinicalTrials.gov Archive Site |
- Change from baseline in neurological outcome as assessed by Extended Glasgow Outcome Scale. [ Time Frame: At week 36 ] [ Designated as safety issue: No ]
- Change from baseline in weight and waist circumference. [ Time Frame: At 36 week ] [ Designated as safety issue: No ]
- Change from baseline in quality of life [ Time Frame: At 36 weeks ] [ Designated as safety issue: No ]
- Change from baseline in lean body mass and fat mass. [ Time Frame: At Week 36 ] [ Designated as safety issue: No ]
- Change from baseline in cardiovascular risk. [ Time Frame: At 36 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in CogState™. [ Time Frame: At Week 12 and 24 ] [ Designated as safety issue: No ]
|
- Change from baseline in CogState. [ Time Frame: At Week 12 and 24 ]
- Change from baseline in lean body mass and fat mass. [ Time Frame: At Week 36 ]
- Change from baseline in neurological outcome as assessed by Extended Glasgow Outcome Scale. [ Time Frame: At week 36 ]
- Change from baseline in quality of life [ Time Frame: At week 36. ]
- Change from baseline in cardiovascular risk.
- Change from baseline in weight and waist circumference.
|
| |
| 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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
- Brain Injuries
- Growth Hormone Deficiency
|
- Drug: Genotropin
- Drug: Placebo
|
| Experimental: Not Specified |
| |
| |
| 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
- History of benign intracranial hypertension
|
| Both |
| 18 Years to 55 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France, Italy, Netherlands, Spain, Sweden, United Kingdom |
| |
| NCT00555009 |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| A6281289 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| March 2009 |
