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| Sponsor: | Mount Sinai School of Medicine |
|---|---|
| Collaborator: |
U.S. Department of Education |
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00488969 |
Purpose
We would like to learn if a medicine called "modified-release morphine sulfate" (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. "Modified-release" means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain Spinal Cord Injury |
Drug: Modified-release morphine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury |
| Estimated Enrollment: | 48 |
| Study Start Date: | July 2007 |
Neuropathic pain occurs as a result of damage to neural tissue either in the peripheral or in the central nervous system. Three types of neuropathic pain after SCI are especially difficult to treat: at level central pain (ALCP), at level radicular pain (ALRP), and below level central pain (BLCP). Various analgesic medications with distinct mechanisms and sites of action are currently used in clinical practice for treatment of neuropathic pain after SCI, including antidepressants, anticonvulsants, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. These analgesic medications, when evaluated in animal models of SCI pain and in the treatment of other neuropathic pain states, have been shown to have only modest pain reducing effect. This modest effect is seen clinically as the majority of persons with SCI receiving these drugs continue to experience pain, which is severe and disabling in one third of cases.
This study proposes to examine the efficacy of oral modified release morphine in reducing pain in persons with neuropathic pain after SCI who have not adequately responded to other oral pharmacologic, psychologic, or physical interventions. Only subjects who have failed prior pain treatment regimes will be enrolled. Failure of pain regimen is defined as the presence of pain in spite of medication(s) or other pain treatment, such as biofeedback or other psychological or physical therapy interventions prescribed by a physician.
The following hypothesis will be tested: morphine, when added to non-opioid medications, is more effective than placebo in reducing pain and increasing activity and subjective well-being, in persons with ALCP, ALRP and BLCP. In order to test this hypothesis, a randomized, double blind, placebo-controlled, two period cross-over trial is proposed, during which subjects with ALCP, ALRP, and BLCP will receive daily placebo or modified release morphine while being closely monitored and assessed for: (1) adverse effects, (2) quality and intensity of pain, (3) intensity of allodynia and hyperalgesia, and (4) activity levels and well-being.
All subjects whether assigned to the placebo or active drug will be able to continue any previously prescribed or non-prescribed (over-the-counter) non-opioid medication that has been taken on a regular basis, without dose change, for at least three weeks prior to study entry. These medications may include but are not limited to the analgesics: acetaminophen and any non-steroidal anti-inflammatory drugs; local anesthetics- topical patches such as the lidocaine patch or otherwise; and adjuvant pain medications of the anti-depressant or anticonvulsant classes. Subjects will not be allowed to take any opioid medication, including non-opioid-opioid combination analgesics, other than the study drug for the duration of the study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Anousheh Behnegar, MD | 212-659-9379 | Anousheh.Behnegar@mountsinai.org |
| Contact: Jeanne M Zanca, PhD, MPT | 212-659-9349 | Jeanne.Zanca@mountsinai.org |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: Thomas Bryce, MD | |
| Sub-Investigator: Anousheh Behnega, MD | |
| Sub-Investigator: Howard Choi, MD | |
| Sub-Investigator: Marcel Dijkers, MD | |
| Sub-Investigator: Steven Flanagan, MD | |
| Sub-Investigator: Wayne Gordon, MD | |
| Sub-Investigator: Kristjan Ragnarsson, MD | |
| Sub-Investigator: Adam Stein, MD | |
| Sub-Investigator: Jeanne Zanca, PhD, MPT | |
| Principal Investigator: | Thomas Bryce, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | H133N060027, GCO # 90-135 |
| Study First Received: | June 19, 2007 |
| Last Updated: | July 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00488969 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Morphine Chronic Pain Spinal Cord Injury Neuropathic Pain |
|
Morphine Neuralgia Spinal Cord Diseases Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Central Nervous System Depressants Central Nervous System Diseases Disorders of Environmental Origin Narcotics Pain Trauma, Nervous System |
Pharmacologic Actions Spinal Cord Injuries Signs and Symptoms Neuromuscular Diseases Sensory System Agents Therapeutic Uses Peripheral Nervous System Diseases Neurologic Manifestations Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |