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NCT00733096 · ClinicalTrials.gov registry record · Phase 2
A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT00733096: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00733096 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 84 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00733096, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the results showed significant benefit in favor of the etanercept group, but no subject was included with a duration of pain \> 9 months, and the results of this study have yet to be replicated. Currently, epidural steroid injections are the most frequently performed procedures in pain clinics across the U.S. However, epidural steroids may benefit only a select group of patients. The literature on treating sciatica is notable for a lack of randomized comparative studies involving various treatments. The objective of this project is to conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral radiculopathy.
Interventions
- DRUG methylprednisolone
- DRUG normal saline
- DRUG etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00733096
The ClinicalTrials.gov registry entry for NCT00733096 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which methylprednisolone is the first listed.
NCT00733096 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00733096 about?
NCT00733096 is a clinical study titled "A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy". Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural e...
What is the current status of trial NCT00733096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2008-08. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00733096?
The interventions under investigation include: methylprednisolone (DRUG), normal saline (DRUG), etanercept (DRUG).
Who is sponsoring clinical trial NCT00733096?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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