Neurogenic Intermittent Claudication Clinical Trial
Official title:
Lumbar Stenosis Outcomes Research II: Opana IR Versus Placebo and Active Control for the Treatment of Walking Impairment in Lumbar Spinal Stenosis: A Double-Blind Randomized, Cross-Over Trial
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 with
neurogenic intermittent claudication. 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 tolerance.
The proposed study will also provide the foundation for a treadmill-based methodology for
assessing the analgesic efficacy of drugs for low back pain provoked by standing and walking
associated with lumbar spinal stenosis.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00638443 -
Lumbar Stenosis Outcomes Research (LUSTOR)
|
Phase 4 |