Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: AZD1940 (Drug); Naproxen (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lynn Webster, MD, Principal Investigator, Affiliation: Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
Mark Borsody, Study Chair, Affiliation: AstraZeneca Pharmaceuticals1800 Concord PikeWilmington, DE 19850-5437USA
Overall contact:
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To investigate the analgesic effect of AZD1940 800ug compared to placebo in dental surgery patients following impacted mandibular third molar extraction.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Research Site, Salt Lake City, Utah, United States; Recruiting
Additional Information
Starting date: February 2008
Ending date: May 2008
Last updated: April 15, 2008
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