Perioperative Pain Clinical Trial
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
NCT number | NCT00298636 |
Other study ID # | ADO-122 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | February 28, 2006 |
Last updated | August 1, 2006 |
Start date | October 2005 |
Verified date | August 2006 |
Source | Xsira Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Georgia | Augusta | Georgia |
United States | University of Chicago | Chicago | Illinois |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Memorial Hermann-Memorial City Hospital | Houston | Texas |
United States | University of Miami/Miller School of Medicine | Miami | Florida |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
United States | Wake Forest University/Forsyth Medical Center | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Xsira Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-response | |||
Secondary | efficacy |
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