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AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

NCT ID: NCT00939094

Last Updated: 2012-09-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

Detailed Description

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Conditions

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Neuropathic Pain Mechanical Hypersensitivity

Keywords

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Pain, Mechanical Hypersensitivity Allodynia Efficacy analgesia Neuropathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

AZD2066

Intervention Type DRUG

Capsule, once daily

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, once daily

Interventions

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AZD2066

Capsule, once daily

Intervention Type DRUG

Placebo

Capsule, once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent prior to any study specific procedures.
* Male or non-fertile females
* Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria

* Other pain that may confound assessment of neuropathic pain.
* Diagnosis of any severe neurological disease.
* History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Biljana Lilja

Role: STUDY_DIRECTOR

AstraZeneca R&D Södertälje151 85 Södertälje, Sweden

Brett Stacey

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University Comprehensive Pain Clinic, Portland, OR 97239, USA

Locations

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Walnut Creek, California, United States

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Boulder, Colorado, United States

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Atlantis, Florida, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Orlando, Florida, United States

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Palm Beach Gardens, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Sunrise, Florida, United States

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Canton, Georgia, United States

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Marietta, Georgia, United States

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Evansville, Indiana, United States

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New Orleans, Louisiana, United States

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Brockton, Massachusetts, United States

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Bingham Farms, Michigan, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Lumberton, New Jersey, United States

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Willingboro, New Jersey, United States

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Albuquerque, New Mexico, United States

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Jacksonville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Kettering, Ohio, United States

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Portland, Oregon, United States

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Bridgeville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Irving, Texas, United States

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Lexington, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, United States

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Countries

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United States

Other Identifiers

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D0475C00016

Identifier Type: -

Identifier Source: org_study_id