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NCT00652093 · ClinicalTrials.gov registry record · Phase 4
Lumbar Stenosis Outcomes Research II
A Phase 4 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00652093: Clinical Trial Phase 4 study, sponsored by University of Rochester.
NCT00652093 is a Phase 4 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00652093, a Phase 4 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of 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 oxymorphone hydrochloride and propoxyphene/acetaminophen combination 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. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.
Interventions
- DRUG opana then darvocet then placebo
- DRUG opana then placebo then darvocet
- DRUG placebo then opana then darvocet
- DRUG Placebo then darvocet then opana
- DRUG Darvocet then opana then placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
Why NCT00652093 stopped before completion
NCT00652093 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which opana then darvocet then placebo is the first listed.
NCT00652093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00652093 about?
NCT00652093 is a clinical study titled "Lumbar Stenosis Outcomes Research II". The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinic...
What is the current status of trial NCT00652093?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2008-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00652093?
The interventions under investigation include: opana then darvocet then placebo (DRUG), opana then placebo then darvocet (DRUG), placebo then opana then darvocet (DRUG), Placebo then darvocet then opana (DRUG), Darvocet then opana then placebo (DRUG).
Who is sponsoring clinical trial NCT00652093?
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 NCT00652093's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 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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