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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

NCT00555009 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-06-02

Study results available
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Summary

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Conditions

  • Brain Injuries
  • Growth Hormone Deficiency

Interventions

DRUG

Genotropin

Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.

DRUG

Placebo

Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • France
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555009 on ClinicalTrials.gov