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Sponsors and Collaborators: |
Wake Forest University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00349921 |
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
Condition | Intervention | Phase |
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Pain |
Drug: clonidine Drug: adenosine Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment |
Official Title: | Clonidine Versus Adenosine to Treat Neuropathic Pain |
Estimated Enrollment: | 28 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
clonidine
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Drug: clonidine
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.
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2: Active Comparator
adenosine
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Drug: adenosine
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.
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3: Placebo Comparator |
Other: placebo
inactive substance
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
The Center for Clinical Research, 145 Kimel Park Drive | |
Winston-Salem, North Carolina, United States, 27103 | |
Wake Forest University School of Medicine, Medical Center Boulevard | |
Winston-Salem, North Carolina, United States, 27157-1009 |
Principal Investigator: | James C. Eisenach, M.D. | Wake Forest University |
Principal Investigator: | Richard Rauck, M.D. | The Center for Clinical Research |
Responsible Party: | Wake Forest University School of Medicine ( James C. Eisenach, MD, Professor of Anesthesiology ) |
Study ID Numbers: | P01NS041386_TRIAL1, BG 04-280 |
Study First Received: | July 5, 2006 |
Last Updated: | May 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00349921 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pain chronic pain clonidine adenosine |
complex regional pain syndrome CRPS a2-adrenergic agonists alpha2-adrenergic agonists |
Vasodilator Agents Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Clonidine Pain Cardiovascular Agents |
Antihypertensive Agents Adrenergic Agonists Complex Regional Pain Syndromes Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Adenosine |
Sympatholytics Neurotransmitter Agents Vasodilator Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Clonidine Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Adenosine Central Nervous System Agents |