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Sponsors and Collaborators: |
University of Rochester Endo Pharmaceuticals |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00652093 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo
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Drug: Placebo
Pill
|
2: Active Comparator
Darvocet & Opana
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Drug: Propoxyphene/acetaminophen
Pill, 100 mg/650 mg
Drug: oxymorphone hydrochloride
Pill, 5mg IR
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nicole Murray | 585-340-8928 | nicole_murray@urmc.rochester.edu |
United States, New York | |
2180 S. Clinton Ave | Recruiting |
Rochester, New York, United States, 14618 | |
Contact: John Markman, MD 585-276-3217 John_Markman@urmc.rochester.edu |
Principal Investigator: | John D Markman, M.D. | University of Rochester |
Responsible Party: | Director, Tanslational Pain Research ( John D. Markman, M.D. ) |
Study ID Numbers: | 20957 |
Study First Received: | March 11, 2008 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00652093 |
Health Authority: | United States: Institutional Review Board |
Arterial Occlusive Diseases Signs and Symptoms Dextropropoxyphene Vascular Diseases Intermittent Claudication Constriction, Pathologic |
Arteriosclerosis Acetaminophen Spinal Stenosis Naloxone Oxymorphone |
Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |