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NCT00638443 · ClinicalTrials.gov registry record · Phase 4
Lumbar Stenosis Outcomes Research (LUSTOR)
A Phase 4 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT00638443 is a Phase 4 study that has completed, run by University of Rochester. The registered enrollment target is 29 participants.
The verdict
NCT00638443, a Phase 4 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of pregabalin with respect to improvement in duration and distance of walking.
Interventions
- DRUG Diphenhydramine
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00638443
The ClinicalTrials.gov registry entry for NCT00638443 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diphenhydramine is the first listed.
NCT00638443 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00638443 about?
NCT00638443 is a clinical study titled "Lumbar Stenosis Outcomes Research (LUSTOR)". The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, nu...
What is the current status of trial NCT00638443?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2008-03. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00638443?
The interventions under investigation include: Diphenhydramine (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00638443?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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