A Study to Evaluate the Efficacy of Somatropin in Adults With Growth Hormone Deficiency Caused by Trauma and/or Head Injury (GHD)

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Growth Hormone Deficiency Dwarfism; Brain Injuries

Treatments: Genetic: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00638053

GENGHD-0018-078

Details and patient eligibility

About

The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury

Full description

The study was terminated on October 9, 2003. The reason cited for the termination was due to poor patient recruitment and therefore not enough data could be collected to provide comprehensive analysis for reporting of results. No safety or efficacy issues were reported to cause the termination of the study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented GHD
• Documented mild, moderate, and severe head injury (e.g.,Glasgow COMA Scale score less than or equal to 15 or equivalent measure)

Exclusion criteria

• Active systemic malignancy or active intracranial tumor
• Growth hormone replacement therapy in the last 12 months
• History of dementia unrelated to traumatic brain injury

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

1

Experimental group

Treatment:

Genetic: somatropin