Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: AZD1940; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00659490

D3120C00006

Details and patient eligibility

About

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.

Enrollment: 151 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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151 participants in 3 patient groups, including a placebo group

AZD1940

Experimental group

Description:

AZD1940 800ug given predose

Treatment:

Drug: AZD1940

Naproxen

Active Comparator group

Description:

Naproxen 500mg given pre-surgery

Treatment:

Drug: Naproxen

Placebo

Placebo Comparator group

Description:

Placebo given pre-surgery

Treatment:

Drug: Placebo