A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

NCT ID: NCT01200524

Last Updated: 2014-04-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

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A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Detailed Description

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Conditions

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Nerve Pain

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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AZD2423, 20mg

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

20 mg tablet

AZD2423, 150 mg

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

50 mg tablet

Placebo

Tablet to match the 20 mg and 50 mg AZD2423 active tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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AZD2423

20 mg tablet

Intervention Type DRUG

AZD2423

50 mg tablet

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed informed consent form
* Males and female patients aged 18 to 80 years
* Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery

Exclusion Criteria

* Other paint that may confound assessment of neuropathic pain
* History of treatment failure with more than three adequate trials of treatment for neuropathic pain
* Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Bror Jonzon

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Pleven, , Bulgaria

Site Status

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Sofia, , Bulgaria

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Aalborg, , Denmark

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Odense, , Denmark

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Boulogne-Billancourt, , France

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Clermont-Ferrand, , France

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Nice, , France

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Saint-Priest-en-Jarez, , France

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Gdansk, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Poznan, , Poland

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Tychy, , Poland

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Warsaw, , Poland

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Falköping, , Sweden

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Kristianstad, , Sweden

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Stockholm, , Sweden

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Birmingham, , United Kingdom

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Bradford, , United Kingdom

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Glasgow, , United Kingdom

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Manchester, , United Kingdom

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Countries

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Bulgaria Denmark France Poland Russia Sweden United Kingdom

Other Identifiers

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D2600C00012

Identifier Type: -

Identifier Source: org_study_id

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