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

This study has been terminated.
(See reason for termination in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00638053
First received: March 11, 2008
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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


Condition Intervention Phase
Brain Injuries
Growth Hormone Deficiency Dwarfism
Genetic: somatropin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in the serum Insulin-like growth factor-I (IGF-I)concentration from baseline [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
  • Number of patients with abnormal GH stimulation tests [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in waist circumference [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Age and gender specific optimal doses of GH replacement [ Time Frame: Months 1 thru 11 ] [ Designated as safety issue: No ]
  • Change in Quality of Life-Adult Growth Hormone Deficiency Assessment [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
  • Assessment of adverse events [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change from baseline in Glasgow Outcome Score [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change in Quality of Life-Mini-Mental scores [ Time Frame: Months 1 thru 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2002
Study Completion Date: November 2003
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638053

Locations
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Pfizer Investigational Site
El Paso, Texas, United States, 79925
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Washington
Pfizer Investigational Site
Federal Way, Washington, United States, 98003
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00638053     History of Changes
Other Study ID Numbers: GENGHD-0018-078
Study First Received: March 11, 2008
Last Updated: March 27, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Craniocerebral Trauma
Brain Injuries
Endocrine System Diseases
Wounds and Injuries
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 27, 2014