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| ID | Type | Description | Link |
|---|---|---|---|
| P01NS041386 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clonidine first, then adenosine | Active Comparator | clonidine given in first injection adenosine given in second injection |
|
| adenosine first, then clonidine | Active Comparator | adenosine given in first injection clonidine given in second injection |
|
| clonidine given first, then placebo | Placebo Comparator | placebo |
|
| adenosine given first, then placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clonidine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number Meeting Success Criterion | Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection | baseline and 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C. Eisenach, M.D. | Wake Forest University Health Sciences | Principal Investigator |
| Richard Rauck, M.D. | The Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Clinical Research, 145 Kimel Park Drive | Winston-Salem | North Carolina | 27103 | United States | ||
24 subjects consented and enrolled 2 subjects withdrawn prior to group assignment because they did not meet inclusion / exclusion criteria on second review
24 Subjects with chronic pain were recruited from the Center for Clinical Research. Each subject was scheduled for a study visit and randomized to receive spinal clonidine, spinal adenosine or placebo. The subject was scheduled for a second study visit and received the opposite treatment from the first visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clonidine First, Then Adenosine | Clonidine given during the first period and adenosine given during the second period |
| FG001 | Adenosine First, Then Clonidine | Adenosine given during the first period and adenosine given during the second |
| FG002 | Clonidine First, Then Placebo | Clonidine given as during the first period, then placebo during the second |
| FG003 | Adenosine First, Then Placebo | Adenosine given during the first period and placebo given during the second |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Spinal Injection |
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| ||||||||||||||||||
| Second Spinal Injection |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clonidine First, Then Adenosine | clonidine given in first injection adenosine given in second injection |
| BG001 | Adenosine Given First, Then Clonidine | adenosine given in first injection clonidine given in second injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Meeting Success Criterion | Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection | The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain. | Posted | Number | participants meeting success criterion | baseline and 2 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clonidine First, Then Adenosine | clonidine given in first injection adenosine given in second injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regina Curry, RN, CCRC | Wake Forest University Health Sciences | (336) 716-4294 | recurry@wfubmc.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001342 | Autonomic Nervous System Diseases |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| adenosine | Drug | 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. |
|
| placebo | Drug | inactive substance |
|
|
| placebo | Drug | inactive substance |
|
|
| Wake Forest University School of Medicine, Medical Center Boulevard |
| Winston-Salem |
| North Carolina |
| 27157-1009 |
| United States |
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Clonidine Given First, Then Placebo | clonidine given first placebo given in second injection |
| BG003 | Adenosine First, Then Placebo | adenosine given in first injection placebo given in second injection |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo received as either first or second injection |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Adenosine First, Then Clonidine | adenosine given in first injection clonidine given in second injection | 0 | 11 | 0 | 11 |
| EG002 | Clonidine First, Then Placebo | clonidine given first placebo given in second injection | 0 | 1 | 0 | 1 |
| EG003 | Adenosine First, Then Placebo | adenosine given in first injection placebo given in second injection | 0 | 1 | 0 | 1 |
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| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D006571 |
| Heterocyclic Compounds |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |