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NCT00766038 · ClinicalTrials.gov registry record · Phase 2
Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00766038: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00766038 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766038, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI) requiring inpatient rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this population. Further, the major effector molecule of the somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an important neurotrophic agent. Since most repair and regeneration after TBI occurs within the first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the subacute period after TBI are potentially important factors why some patients fail to make a good functional recovery. The proposed study is a randomized, double-blind, placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months. This study has one primary hypothesis, that treatment with recombinant human Growth Hormone (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose GH deficiency in TBI survivors and study the relationship between GH deficiency and insufficiency and functional recovery.
Primary Outcome
Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal
Interventions
- DRUG Placebo
- DRUG Recombinant human Growth Hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT00766038 record still lists
NCT00766038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00766038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00766038 about?
NCT00766038 is a clinical study titled "Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.". Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI) requiring inpatient rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this popu...
What is the current status of trial NCT00766038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2008-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00766038?
The interventions under investigation include: Placebo (DRUG), Recombinant human Growth Hormone (DRUG).
Who is sponsoring clinical trial NCT00766038?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00766038's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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