Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury.

Brain Injuries Clinical Trial

Official title:

Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Patients With Growth Hormone Deficiency After Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00432263
• Other study ID #: A6281274
• Status: Withdrawn
• Phase: Phase 4
• First received: February 5, 2007
• Last updated: April 21, 2015
• Start date: April 2007

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unknown:
• Study type: Interventional

Clinical Trial Summary

To establish the effects of genotropin replacement in patients with severe growth hormone deficiency after traumatic brain injury on cognitive function.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Dwarfism, Pituitary

Intervention

Drug:
• Genotropin (PN-180,307) Somatropin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.
Secondary	Change CogState™ at Week 12, 24, 60 and 72. Change in lean body mass and fat mass at Week 36 and 72. Change in the Extended Glasgow Outcome Scale at week 36 and 72. Change in quality of life at week 24, 36, 60 and 72. Summary of change in cardiovascular

External Links

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