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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: Completed Phase 4 study, sponsored by University of Rochester.
NCT00638443 is a Phase 4 study that has completed, run by University of Rochester. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.
Interventions
- DRUG Diphenhydramine
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-09 |
| Phase | Phase 4 |
What the finished NCT00638443 record still lists
NCT00638443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Diphenhydramine is the first listed.
NCT00638443 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00638443's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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