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

NCT00638053 | Terminated Phase 4

• 1 other identifier: GENGHD-0018-078
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Brain Injuries; Growth Hormone Deficiency Dwarfism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (1)

1

EXPERIMENTAL

Genetic: somatropin

Interventions

somatropin GENETIC

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15212, United States

Location

Pfizer Investigational Site

El Paso, Texas, 79925, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84102, United States

Location

Pfizer Investigational Site

Federal Way, Washington, 98003, United States

Location

Related Links

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

MeSH Terms

Conditions

Brain Injuries; Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: November 1, 2002
• Study Completion: November 1, 2003
• Last Updated: April 1, 2008

Record last verified: 2008-03

Locations

US (4)