Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: AZD1386 (Drug); Naproxen (Drug); Placebo (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 19850-5437
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 AZD1386 can relieve the pain induced by
the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of
AZD1386 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 Double-Blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: Sum of pain intensity difference in percent (SPID%)
Secondary outcome: Pain intensity (PI) by using Visual Analogue Scale (VAS) (0-100 mm)Time to first perceptible pain relief and time to first meaningful pain relief (based on stopwatches) Visual Analogue Scale (VAS) pain intensity at rescue intake
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.
Exclusion Criteria:
- History of somatic disease/condition, which may interfere with the objectives for the
study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior
to the administration of the investigational product, as judged by the investigator.
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst
first degree relatives
- Patients with a body temperature >37. 5°C at Visit 2, before start of surgical
procedures
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: April 2008
Ending date: June 2008
Last updated: May 5, 2008
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