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Sponsored by: |
Xsira Pharmaceuticals |
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Information provided by: | Xsira Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00298636 |
Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.
Condition | Intervention | Phase |
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Perioperative Pain |
Drug: adenosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Escalating Dose-Response Trial of Intravenous Adenosine for Perioperative Analgesia in Females Undergoing Abdominal Hysterectomy or Myomectomy |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Florida | |
University of Miami/Miller School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Wake Forest University/Forsyth Medical Center | |
Winston Salem, North Carolina, United States, 27157 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Memorial Hermann-Memorial City Hospital | |
Houston, Texas, United States, 77024 |
Principal Investigator: | Tong J Gan, M.D. | Duke University |
Study ID Numbers: | ADO-122 |
Study First Received: | February 28, 2006 |
Last Updated: | August 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00298636 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Vasodilator Agents Pain Cardiovascular Agents Anti-Arrhythmia Agents |
Peripheral Nervous System Agents Analgesics Adenosine |
Vasodilator Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Cardiovascular Agents Anti-Arrhythmia Agents |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Adenosine Pharmacologic Actions |