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Lumbar Stenosis Outcomes Research II (LUSTORII)

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00652093
First received: March 11, 2008
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  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 4

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
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:

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 May 23, 2013