Lumbar Stenosis Outcomes Research II - Full Text View

Sponsor:	University of Rochester
Collaborator:	Endo Pharmaceuticals
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00652093

Purpose

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.

Condition	Intervention	Phase
Neurogenic Intermittent Claudication	Drug: Placebo Drug: Propoxyphene/acetaminophen Drug: oxymorphone hydrochloride	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Spinal Stenosis

Drug Information available for: Propoxyphene napsylate Distalgesic Levopropoxyphene napsylate Oxymorphone Acetaminophen CT 2584 Oxymorphone hydrochloride Propoxyphene Propoxyphene hydrochloride Levopropoxyphene

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Time to first symptoms (Tfirst) on the treadmill walking test. [ Time Frame: 1.5 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Area under the curve of present pain intensity with ambulation at each cued time point [ Time Frame: Every 30 seconds for a maximum of 15 minutes ] [ Designated as safety issue: Yes ]
Walking tolerance as measured by time and distance walked on the treadmill walking test [ Time Frame: 1.5 hours ] [ Designated as safety issue: Yes ]
BPI Interference Measure [ Time Frame: 0 ] [ Designated as safety issue: No ]
Time to return to baseline pain level after the treadmill ambulation assessment (Trecovery) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
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.) [ Time Frame: 6 Months - 1 year ] [ Designated as safety issue: Yes ]
Patient Global Impression of Change [ Time Frame: 0 ] [ Designated as safety issue: No ]
Oswestry Disability Index score, Swiss Spinal Stenosis score, Patient Global Impression of Change, and Roland Morris Disability Questionnaire. [ Time Frame: 15 min ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2008
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Pill
Active Comparator: 2 Darvocet & Opana	Drug: Propoxyphene/acetaminophen Pill, 100 mg/650 mg Other Name: Darvocet Drug: oxymorphone hydrochloride Pill, 5mg IR Other Name: Opana

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652093

Locations

United States, New York
2180 S. Clinton Ave
Rochester, New York, United States, 14618

Sponsors and Collaborators

University of Rochester

Endo Pharmaceuticals

Investigators

Principal Investigator:

John D Markman, M.D.

University of Rochester

More Information

Publications:

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.

Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. Review.

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.

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. 1998 Jan 15;23(2):244-8.

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. 1996 Apr 1;21(7):796-803.

Responsible Party:	John D. Markman, M.D., Director, Tanslational Pain Research
ClinicalTrials.gov Identifier:	NCT00652093 History of Changes
Other Study ID Numbers:	20957
Study First Received:	March 11, 2008
Last Updated:	January 5, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Acetaminophen
Dextropropoxyphene
Oxymorphone
Antipyretics
Physiological Effects of Drugs

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on February 09, 2012