Ignite Creation Date:
2024-05-05 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00652093
Status:
TERMINATED
Last Update Posted:
2016-03-25
First Post:
2008-03-11
Brief Title:
Lumbar Stenosis Outcomes Research II
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Lumbar Stenosis Outcomes Research II Opana IR Versus Placebo and Active Control Darvocet for the Treatment of Walking Impairment in Lumbar Spinal Stenosis A Double-Blind Randomized Cross-Over Trial
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Removal of Darvocet from US market
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUSTORII
Brief Summary:
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxypheneacetaminophen 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 propoxypheneacetaminophen combination with respect to improvement in duration and distance of walking
Detailed Description:
A computer-generated randomization plan was used for assignment of subjects to one of six treatment sequences 4 subjects per sequence oxymorphonepropoxypheneplacebo oxymorphoneplacebopropoxyphene placebooxymorphonepropoxyphene placebopropoxypheneoxymorphone propoxypheneoxymorphoneplacebo or propoxypheneplacebooxymorphone One dose of blinded study drug opana propoxypehen or placebo was given at study days 1 5 and 9 The primary endpoint was time to first symptoms of moderate intensity NRS 410 during treadmill ambulation Ambulation assessment was performed during the screening visit Ambulation assessment was also performed 90 minutes after administration of study drug on days 1 5 and 9 to evaluate pain intensity associated with walking as well as distance covered by the patients Quantitative assessment of ambulation was conducted on a treadmill at 0 ramp incline at 12 miles per hour mph Measurement of self-reported symptom severity using the NRS at baseline and every 30 seconds for a maximum of 15 minutes was recorded The following information was also recorded time to first symptoms total ambulation time The examination was stopped after 15 minutes or at the onset of severe symptoms Severe symptoms were defined as the level of discomfort that would make patients stop walking in usual life situations No one was encouraged or prompted to continue walking beyond this point Patients were instructed to walk with an upright posture They were not permitted to lean forward or hold onto the handrails during the examination Secondary outcome measures included area under the curve of present pain intensity with ambulation at each specified time point final pain intensity with walking walking tolerance time to return to baseline pain level after ambulation as well as the results of a series of pain related questionnaires including Visual Analog Scale VAS Patient Global Assessment PGA NRS Roland Morris Disability Questionnaire RMDQ modified Brief Pain Inventory short form mBPI-sf Oswestry Disability Index ODI and Swiss Spinal Stenosis SSS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None