Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 28, 2006
August 1, 2006
October 2005
Not Provided
Dose-response
Same as current
Complete list of historical versions of study NCT00298636 on ClinicalTrials.gov Archive Site
efficacy
Same as current
Not Provided
Not Provided
 
Dose-Response of Adenosine for Perioperative Pain
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Perioperative Pain
Drug: adenosine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Not Provided
Not Provided

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;
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298636
ADO-122
Not Provided
Not Provided
Xsira Pharmaceuticals
Not Provided
Principal Investigator: Tong J Gan, M.D. Duke University
Xsira Pharmaceuticals
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP