Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.
NCT00432263
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Adult Trials: 18+ Years
- 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.
- 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.
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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 Summary | To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Brain Injuries | |||
| Intervention ICMJE | Drug: Genotropin (PN-180,307) Somatropin | |||
| Study Arms ICMJE | Not Provided | |||
| 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| Recruitment Status ICMJE | Withdrawn | |||
| Actual Enrollment ICMJE | 0 | |||
| Original Enrollment ICMJE | 120 | |||
| Study Completion Date ICMJE | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00432263 | |||
| Other Study ID Numbers ICMJE | A6281274 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||