Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488969
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2007-06-19
Brief Title:
Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 medications 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
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 medications 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCO 90-135 | None | None | None |