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

PHASE4TerminatedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 30, 2002

Study Completion Date

November 30, 2003

Conditions
Brain InjuriesGrowth Hormone Deficiency Dwarfism
Interventions
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

Trial Locations (4)

15212

Pfizer Investigational Site, Pittsburgh

79925

Pfizer Investigational Site, El Paso

84102

Pfizer Investigational Site, Salt Lake City

98003

Pfizer Investigational Site, Federal Way

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY