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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AZD1386

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

95mg, oral solution, single dose

Naproxen

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

500mg, capsule, single dose

Placebo

Placebo matching AZD1386

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

AZD1386 Placebo oral solution

Interventions

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AZD1386

95mg, oral solution, single dose

Intervention Type DRUG

Naproxen

500mg, capsule, single dose

Intervention Type DRUG

Placebo

AZD1386 Placebo oral solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes