Neurogenic Intermittent Claudication Clinical Trial
— LUSTORIIOfficial 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
| NCT number | NCT00652093 |
| Other study ID # | 20957 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | March 11, 2008 |
| Last updated | January 5, 2011 |
| Start date | March 2008 |
| Verified date | January 2011 |
| Source | University of Rochester |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 - Leg/low back pain ratio must be greater than 50:50 - 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). |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | 2180 S. Clinton Ave | Rochester | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rochester | Endo Pharmaceuticals |
United States,
Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. — View Citation
Deen HG, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Use of the exercise treadmill to measure baseline functional status and surgical outcome in patients with severe lumbar spinal stenosis. Spine (Phila Pa 1976). 1998 Jan 15;23(2):244-8. — View Citation
Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. Review. — View Citation
Simon LS, Evans C, Katz N, Bombardier C, West C, Robbins J, Copley-Merriman C, Markman J, Coombs JH. Preliminary development of a responder index for chronic low back pain. J Rheumatol. 2007 Jun;34(6):1386-91. — View Citation
Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976). 1996 Apr 1;21(7):796-803. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first symptoms (Tfirst) on the treadmill walking test. | 1.5 hours | Yes | |
| Secondary | Area under the curve of present pain intensity with ambulation at each cued time point | Every 30 seconds for a maximum of 15 minutes | Yes | |
| Secondary | Walking tolerance as measured by time and distance walked on the treadmill walking test | 1.5 hours | Yes | |
| Secondary | BPI Interference Measure | 0 | No | |
| Secondary | Time to return to baseline pain level after the treadmill ambulation assessment (Trecovery) | 15 minutes | No | |
| Secondary | Adverse events (decrease in respiratory rate, sedation, constipation, low blood, nausea and vomiting, or itching graded on a 0-3 scale (0:none, 1:mild, 2:moderate, 3:severe.) | 6 Months - 1 year | Yes | |
| Secondary | Patient Global Impression of Change | 0 | No | |
| Secondary | Oswestry Disability Index score, Swiss Spinal Stenosis score, Patient Global Impression of Change, and Roland Morris Disability Questionnaire. | 15 min | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00638443 -
Lumbar Stenosis Outcomes Research (LUSTOR)
|
Phase 4 |