Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT00672646

Run by

AstraZeneca

People needed

103

Starts

2008-04-01

Expected to finish

2008-06-01

Last updated by the study team

2012-06-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
• Provision of signed informed consent.

You may not qualify if…

• 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

Where it is running

• Research Site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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