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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 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.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2006-05
Est. Completion 2007-12
Phase Phase 1

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT00364572

The ClinicalTrials.gov registry entry for NCT00364572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 6 other Sciatica trials with a reported enrollment target (71% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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