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NCT00957671 · ClinicalTrials.gov registry record · Phase 4
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT00957671: Completed Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
NCT00957671 is a Phase 4 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00957671, a Phase 4 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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).
Primary Outcome
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Interventions
- DRUG Recombinant human growth hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2003-11 |
| Est. Completion | 2015-10 |
| Phase | Phase 4 |
What the finished NCT00957671 record still lists
NCT00957671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant human growth hormone is the first listed.
NCT00957671 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00957671 about?
NCT00957671 is a clinical study titled "Anterior Pituitary Hormone Replacement in Traumatic Brain Injury". 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 h...
What is the current status of trial NCT00957671?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2003-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00957671?
The interventions under investigation include: Recombinant human growth hormone (DRUG).
Who is sponsoring clinical trial NCT00957671?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00957671's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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