Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349921
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2006-07-05
Brief Title:
Clonidine Versus Adenosine to Treat Neuropathic Pain
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Clonidine Versus Adenosine to Treat Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2018-08
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:
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain
Detailed Description:
This study is part of a pain center grant that focuses on how pain especially chronic neuropathic pain alters the response to traditional and non-traditional analgesics pain medications
Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain is FDA-approved for administration via epidural an injection given in the lower back and is the third most commonly prescribed drug for chronic intrathecal an injection into the cerebrospinal fluid use in people with chronic pain
Adenosine-a drug commonly administered intravenously into a vein to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia pain caused by a stimulus that does not normally cause pain after intrathecal but not intravenous administration in people with neuropathic pain
Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord whereas adenosine relieves pain by actions on A1 adenosine receptors Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain Therefore the goal of this study is to determine the effects of clonidine and adenosine on nerve pain
After initial screening baseline measurements and training to learn to estimate pain accurately using thermal heat testing a sample of spinal fluid will be taken from each participant Participants then will be randomly chosen to receive either clonidine adenosine or placebo After receiving the study medication participants will be monitored with their vital signs checked at 30 60 120 180 and 240 minutes
Duration of the study for participants is 2 weeks and includes two visits to the research center each lasting approximately 6 hours
Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain is FDA-approved for administration via epidural an injection given in the lower back and is the third most commonly prescribed drug for chronic intrathecal an injection into the cerebrospinal fluid use in people with chronic pain
Adenosine-a drug commonly administered intravenously into a vein to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia pain caused by a stimulus that does not normally cause pain after intrathecal but not intravenous administration in people with neuropathic pain
Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord whereas adenosine relieves pain by actions on A1 adenosine receptors Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain Therefore the goal of this study is to determine the effects of clonidine and adenosine on nerve pain
After initial screening baseline measurements and training to learn to estimate pain accurately using thermal heat testing a sample of spinal fluid will be taken from each participant Participants then will be randomly chosen to receive either clonidine adenosine or placebo After receiving the study medication participants will be monitored with their vital signs checked at 30 60 120 180 and 240 minutes
Duration of the study for participants is 2 weeks and includes two visits to the research center each lasting approximately 6 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P01NS041386 | NIH | None | httpsreporternihgovquickSearchP01NS041386 |