Lumbar Stenosis Outcomes Research II

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00652093
• Date of registration: 11/03/2008
• Prospective Registration: No
• Primary sponsor: University of Rochester
• Public title: Lumbar Stenosis Outcomes Research II LUSTORII
• Scientific 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
• Date of first enrolment: March 2008
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00652093
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: John D Markman, M.D.
• Affiliation: University of Rochester

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must present with clinical symptoms of neurogenic claudication (exercise
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) and endorse limitation of walking tolerance due to these
symptoms

- Numeric Rating Scale (NRS) for pain = 6 in response to the following question: "Circle
one number (from 0=no pain to 10=worst pain) - How would you rate the worst leg and
lower back pain you experienced during walking last week?"

- Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one
level of lumbar spinal stenosis within 1 year

- Duration of symptoms > 3 months

- Age > 50 years; male or female

Exclusion Criteria:

- Past or present existence of a movement disorder, e.g., Parkinsonism, or an neurologic
disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda
equina compression)

- Cognitive impairment preventing full understanding or participation in the study

- Peripheral vascular disease

- Moderate to severe arthritis of the knee or hip that might severely compromise
ambulation

- Past or present lower extremity peripheral vascular disease

- Serious concomitant medical illness (e.g., heart disease) that might impair ambulation
assessment

- Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion)
within the past 2 years or epidural steroid injection in the preceding 4 months.

- Severe psychiatric disorder

- Mean time to severe symptoms > 15 minutes.

- Epidural steroid treatment within the last three months

- History of drug or alcohol dependence

- Serious intercurrent illness

- Hypersensitivity to oxymorphone hydrochloride

- Hypersensitivity to propoxyphene or acetaminophen

- Severe bronchial asthma or hypercarbia, morphine analogs such as codeine, or any of
the other ingredients of Opana

- Suspicion of paralytic ileus

- Moderate or severe hepatic impairment

- Major conduction abnormality on ECG or cardiac (Bruce protocol) stress test within the
past year.

- Ongoing treatment with a long-acting opioid or regularly-scheduled use of a short
acting opioid (>3 doses/day on four or more days/week).



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Spinal Stenosis

Intervention(s)

Drug: Darvocet then placebo then opana

Drug: opana then darvocet then placebo

Drug: Darvocet then opana then placebo

Drug: placebo then opana then darvocet

Drug: opana then placebo then darvocet

Drug: Placebo then darvocet then opana

Primary Outcome(s)

Time to First Symptoms (Tfirst) of Moderate Pain [Time Frame: study visit]

Secondary Outcome(s)

Oswestry Disability Index (ODI) Score [Time Frame: study visit]

Roland Morris Disability Questionnaire (RMDQ) [Time Frame: study visit]

Area Under the Curve [Time Frame: study visit]

Recovery Time [Time Frame: study visit]

Swiss Spinal Stenosis Score- Symptom Severity [Time Frame: study visit]

Modified Brief Pain Inventory (mBPI)- Interference Score [Time Frame: study visit]

Patient Global Assessment (PGA) [Time Frame: study visit]

Swiss Spinal Stenosis Score- Physical Function [Time Frame: study visit]

Visual Analog Scale (VAS) [Time Frame: study visit]

Final Pain [Time Frame: study visit]

Total Distance [Time Frame: study visit]

Secondary ID(s)

20957

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Endo Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 25/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00652093