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CompletedNCT00298636Updated Aug 2, 2006

Dose-Response of Adenosine for Perioperative Pain

A Phase 2 interventional study of adenosine in Perioperative Pain, sponsored by Xsira Pharmaceuticals. Completed at 8 sites in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-08-02.

Sponsored by Xsira Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Perioperative Pain
03

In context

Lead sponsor

This is the only study on the registry with Xsira Pharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
160 participants

Interventions

  • Drugadenosine
06

What researchers measure

Primary outcomes

  1. Dose-response

Secondary outcomes

  1. efficacy

07

Study locations

8 sites
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • University of Miami/Miller School of Medicine
    Miami, Florida 33136, United States
  • Medical College of Georgia
    Augusta, Georgia 30912, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Wake Forest University/Forsyth Medical Center
    Winston Salem, North Carolina 27157, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Memorial Hermann-Memorial City Hospital
    Houston, Texas 77024, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00298636
Lead sponsor
Xsira Pharmaceuticals
First posted
Mar 2, 2006
Start date
Oct 2005
Last update
Aug 2, 2006

Study contacts

Tong J Gan, M.D.
principal investigator · Duke University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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