Overview

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

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Analgesics
Naproxen
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