Official Title: “A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction”

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: AZD1940
  • 800ug oral administration
• Drug: Naproxen
  • 500mg oral administration

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• To investigate the analgesic effect of AZD1940 800ug compared to placebo in dental surgery patients following impacted mandibular third molar extraction.
  • Safety Issue?: No

Secondary Measures

• To investigate the effects of orally administered AZD1940; the safety and tolerability of orally administered AZD1940; the pharmacokinetics of AZD1940 and the pharmacokinetic/pharmacodynamics of orally administered AZD1940.
  • Safety Issue?: Yes

Inclusion Criteria:

• Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
• Provision of signed informed consent.
• Healthy males or non-fertile females.

Exclusion Criteria:

• History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
• History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Lynn Webster, MD Principal Investigator Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659490

Study ID Number: D3120C00006

ClinicalTrials.gov Identifier: NCT00659490

Health Authority: United States: Food and Drug Administration