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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 5, 2006 | ||||||||
| Last Updated Date | May 12, 2009 | ||||||||
| Start Date ICMJE | August 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Percent change in pain report [ Time Frame: 2 hours following injection of study medication ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Percent change in pain report 2 hour following injection of study medication. | ||||||||
| Change History | Complete list of historical versions of study NCT00349921 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clonidine Versus Adenosine to Treat Neuropathic Pain | ||||||||
| Official Title ICMJE | Clonidine Versus Adenosine to Treat Neuropathic Pain | ||||||||
| Brief Summary | The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment | ||||||||
| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 28 | ||||||||
| Estimated Completion Date | January 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00349921 | ||||||||
| Responsible Party | James C. Eisenach, MD, Professor of Anesthesiology, Wake Forest University School of Medicine | ||||||||
| Study ID Numbers ICMJE | P01NS041386_TRIAL1, BG 04-280 | ||||||||
| Study Sponsor ICMJE | Wake Forest University | ||||||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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