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

NCT ID: NCT00659490

Last Updated: 2012-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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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.

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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AZD1940

AZD1940 800ug given predose

Group Type EXPERIMENTAL

AZD1940

Intervention Type DRUG

800ug oral administration

Naproxen

Naproxen 500mg given pre-surgery

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

500mg oral administration

Placebo

Placebo given pre-surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given pre-surgery

Interventions

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AZD1940

800ug oral administration

Intervention Type DRUG

Naproxen

500mg oral administration

Intervention Type DRUG

Placebo

Placebo given pre-surgery

Intervention Type DRUG

Other Intervention Names

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Naprosyn

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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynn Webster, MD

Role: PRINCIPAL_INVESTIGATOR

Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA

Bror Jonzon

Role: STUDY_CHAIR

AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden

Locations

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Research Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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D3120C00006

Identifier Type: -

Identifier Source: org_study_id

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