CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Recombinant human growth hormonedrug
Likely dose
Recombinant human growth hormone 200 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00957671
NCT00957671Phase 4Completed

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

The University of Texas Medical Branch, Galveston·interventional·Posted Aug 12, 2009·Updated Jun 29, 2018

In Brief

A Phase 4 clinical trial evaluating Recombinant human growth hormone for Growth Hormone Deficiency and Traumatic Brain Injury. Completed, enrolled 15 participants across 2 sites.

Detailed Summary

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2009
Enrollment StartNov 1, 2003
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 16.9 years ago

Interventions

Recombinant human growth hormonedrug

200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)