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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: AZD1386; Drug: Naproxen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672646

D5090C00010

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 3 patient groups, including a placebo group

AZD1386

Experimental group

Treatment:

Drug: AZD1386

Naproxen

Active Comparator group

Treatment:

Drug: Naproxen

Placebo

Placebo Comparator group

Description:

Placebo matching AZD1386

Treatment:

Drug: Placebo