Dose-Response of Adenosine for Perioperative Pain

This study has been completed.
Sponsor:
Information provided by:
Xsira Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00298636
First received: February 28, 2006
Last updated: August 1, 2006
Last verified: August 2006
  Purpose

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
Perioperative Pain
Drug: adenosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Xsira Pharmaceuticals:

Primary Outcome Measures:
  • Dose-response

Secondary Outcome Measures:
  • efficacy

Estimated Enrollment: 160
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female gender; age 18 to 65 years;
  • American Society of Anesthesiology (ASA) physical classification I to III;
  • scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;

Exclusion Criteria:

  • ASA physical classification of IV or V;
  • documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);
  • history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;
  • history of gout;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298636

Locations
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
Sponsors and Collaborators
Xsira Pharmaceuticals
Investigators
Principal Investigator: Tong J Gan, M.D. Duke University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00298636     History of Changes
Other Study ID Numbers: ADO-122
Study First Received: February 28, 2006
Last Updated: August 1, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 15, 2014