Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00555009
• Date of registration: 24/10/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
• Scientific title: Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.
• Date of first enrolment: March 2008
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00555009
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

France, Italy, Netherlands, Spain, Sweden, United Kingdom

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Brain Injuries

Growth Hormone Deficiency

Intervention(s)

Drug: Placebo

Drug: Genotropin

Primary Outcome(s)

Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 [Time Frame: Baseline, Week 36]

Secondary Outcome(s)

Change From Baseline in Lean Body Mass and Fat Mass at Week 36 [Time Frame: Baseline, Week 36]

Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 [Time Frame: Baseline, Week 36]

Change From Baseline in Cardiovascular Risk [Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36]

Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 [Time Frame: Baseline, Week 36]

Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 [Time Frame: Baseline, Week 36]

Change From Baseline in CogState™ at Week 12 and 24. [Time Frame: Baseline, Week 12 and 24]

Change From Baseline in Weight [Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36]

Change From Baseline in Waist Circumference [Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36]

Secondary ID(s)

A6281289

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00555009