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

Head Trauma With Traumatic Brain Injury (TBI): A Multicenter, Phase IV Study to Evaluate the Effects of Genotropin in Adult Patients With Growth Hormone Deficiency (GHD) Caused by Trauma and/or Head Injury

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

Study Overview

• Status: Terminated
• Conditions: Brain Injuries; Growth Hormone Deficiency Dwarfism
• Intervention / Treatment: Genetic: somatropin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Pfizer Investigational Site
  • Texas
    • El Paso, Texas, United States, 79925
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Pfizer Investigational Site
  • Washington
    • Federal Way, Washington, United States, 98003
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1

Genetic: somatropin; Somatropin will be administered as a daily subcutaneous injection; Fixed doses starting with 0.1 mg/day in patients older than 55 years or patients weighing less than 50 kg; all other patients: 0.1 mg/day or 0.2 mg/day (these doses should all be lower than 0.04 mg/kg/week); all patients starting at 0.1 mg/day will have their dose progressively increased in 0.1 mg/day increments to a maximum clinically- and pharmacologically- tolerated plateau dose; all patients starting at 0.2 mg/day will increase in 0.2 mg/day increments; all incremented dose changes will occur at monthly intervals based on IGF-I levels; treatment will continue for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline	Months 1 thru 11
Number of patients with abnormal GH stimulation tests	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in waist circumference	Month 12
Age and gender specific optimal doses of GH replacement	Months 1 thru 11
Change in Quality of Life-Adult Growth Hormone Deficiency Assessment	Months 1 thru 12
Assessment of adverse events	Months 1 thru 12
Serum prolactin, thyroid stimulating hormone, free thyroxine serum, cortisol, adrenocorticotropic hormone, luteinizing hormone, follicle stimulating hormone, estradiol, and testosterone to assess degree of other anterior pituitary hormone deficiencies	Baseline
Change from baseline in Glasgow Outcome Score	Month 12
Change in Quality of Life-Mini-Mental scores	Months 1 thru 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Study Completion (Actual): November 1, 2003

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2008
• Last Update Submitted That Met QC Criteria: March 27, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Trauma, Nervous System; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Bone Diseases, Developmental; Hypopituitarism; Brain Injuries; Wounds and Injuries; Dwarfism, Pituitary; Endocrine System Diseases; Craniocerebral Trauma; Dwarfism
• Other Study ID Numbers: GENGHD-0018-078