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NCT00364572 · ClinicalTrials.gov registry record · Phase 1
Efficacy of Epidural Etanercept in the Treatment of Sciatica
A Phase 1 study of Sciatica, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00364572: Completed Phase 1 study of Sciatica, sponsored by Johns Hopkins University.
NCT00364572 is a Phase 1 study of Sciatica that has completed, run by Johns Hopkins University. The registered enrollment target is 24 participants, below the 83-participant average among 6 other Sciatica trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00364572, a Phase 1 study of Sciatica, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).
Conditions Studied
Interventions
- DRUG epidural injection of etanercept
- DRUG placebo (control procedure)
Study Locations (1)
District of Columbia
- Walter Reed Army Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT00364572 record still lists
NCT00364572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 83-participant average among 6 other Sciatica trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Sciatica appearing as the primary indexed condition, and to 2 interventions - of which epidural injection of etanercept is the first listed.
NCT00364572 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00364572 about?
NCT00364572 is a clinical study titled "Efficacy of Epidural Etanercept in the Treatment of Sciatica". Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and inf...
What is the current status of trial NCT00364572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2006-05. Estimated completion is 2007-12.
What conditions does trial NCT00364572 study?
This clinical trial studies the following conditions: Sciatica.
What interventions are being tested in trial NCT00364572?
The interventions under investigation include: epidural injection of etanercept (DRUG), placebo (control procedure) (DRUG).
Who is sponsoring clinical trial NCT00364572?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00364572 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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