Dose-Response of Adenosine for Perioperative Pain

NCT00298636 | Completed Phase 2

• 1 other identifier: ADO-122
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Perioperative Pain

Outcome Measures

Primary Outcomes (1)

• Dose-response

Secondary Outcomes (1)

• efficacy

Interventions

adenosine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xsira Pharmaceuticals: lead

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami/Miller School of Medicine

Miami, Florida, 33136, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Wake Forest University/Forsyth Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Memorial Hermann-Memorial City Hospital

Houston, Texas, 77024, United States

Location

MeSH Terms

Interventions

Adenosine

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Tong J Gan, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2006
• First Posted: March 2, 2006
• Study Start: October 1, 2005
• Last Updated: August 2, 2006

Record last verified: 2006-08

Locations

US (8)