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Home > "B" Clinical Trials Conditions > Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury  Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury
Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury
For Condition:
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: Bradykinin B1 receptors and their natural agonists are known to be rapidly induced in local tissues by a variety of inflammatory stimuli. Preclinical evidence, demonstrating that interruption of B1 receptor function causes analgesia under a variety of conditions, has been well established using selective antagonists and genetically modified mice. Accordingly, efforts are underway in several laboratories to develop novel B1 receptor antagonists as potential novel analgesic agents. The proposed studies will examine the kinetics of local induction of B1 receptors and kinin formation in a common situation of acute inflammatory pain in humans - tooth extraction. In addition, an examination of expression of additional genes of interest under these conditions using microarray analysis will be conducted.
Details: Bradykinin B1 receptors and their natural agonists are known to be rapidly induced in local tissues by a variety of inflammatory stimuli. Preclinical evidence, demonstrating that interruption of B1 receptor function causes analgesia under a variety of conditions, has been well established using selective antagonists and genetically modified mice. Accordingly, efforts are underway in several laboratories to develop novel B1 receptor antagonists as potential novel analgesic agents. The proposed studies will examine the kinetics of local induction of B1 receptors and kinin formation in a common situation of acute inflammatory pain in humans - tooth extraction. In addition, an examination of expression of additional genes of interest under these conditions using microarray analysis will be conducted.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Male or female volunteers referred for third molar extraction willing to undergo 2 or 3 visits: 1 screening visit; 1 surgical appointment; and a possible follow-up research-related appointment Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation) Willing to undergo observation period for three hours postoperatively Ability to complete a 100 mm visual analog scale and a category scale every 20 minutes for the first 3 postoperative hours Willing to have a microdialysis probe placed beneath the surgical flap during the first 3 hours post-surgery Willing to have a preoperative biopsy on the day of surgery, and a postoperative biopsy either at 3, 7 or 24 hours following surgery Willing to return, if needed, 24 hours post-operation for the postoperative biopsy Must have two lower partial (rating is equal to 3) or fully impacted (rating is equal to 4) wisdom teeth (mandibular third molars) As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels EXCLUSION CRITERIA: Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics Patients who have had asthma, or hives Patients who are pregnant or nursing Patients with history of peptic ulcers and/or GI bleeding Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDs, COX-2 inhibitors, antihistamines, steroids, antidepressants Patients who have clinical signs suggestive of infection, inflammation, or pre-existing pain at either extraction site Patients with severe kidney disease Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; coumadin or other blood thinners Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6 Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery)
Total Enrollment: 90
Location and Contact Information:
National Institute of Dental And Craniofacial Research (NIDCR) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040182; 04-D-0182
Study Start Date: May 20, 2004
Record last reviewed: March 2, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083356
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Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury
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