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Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain

NCT ID: NCT00976534

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-02-28

Brief Summary

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The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

Detailed Description

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Conditions

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Pain Neuropathic Pain

Keywords

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Analgesic effect Peripheral Neuropathic pain Posttraumatic Neuralgia (PTN) Postherpetic Neuralgia (PHN)

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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1

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

90 mg, capsules, oral, during 3 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules, oral, during 3 weeks

Interventions

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AZD1386

90 mg, capsules, oral, during 3 weeks

Intervention Type DRUG

Placebo

capsules, oral, during 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with painful symptoms due to neuropathic pain
* Provision of signed informed consent
* Non pregnant females

Exclusion Criteria

* Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
* History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator
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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AstraZeneca

Principal Investigators

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Richard L Leff, md

Role: STUDY_DIRECTOR

AstraZeneca R&D Wilmington, USA

Rolf Karlsten, MD

Role: STUDY_CHAIR

AstraZeneca R&D Södertälje, Sweden

Locations

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Research Site

Calgary, Alberta, Canada

Site Status

Research Site

Halifax, Nova Scotia, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Aalborg, , Denmark

Site Status

Research Site

Arhus C, , Denmark

Site Status

Research Site

Boulogne-Billancourt, , France

Site Status

Research Site

Clermont-Ferrand, , France

Site Status

Research Site

Nice, , France

Site Status

Research Site

Bradford, , United Kingdom

Site Status

Research Site

Glasgow, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Countries

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Canada Denmark France United Kingdom

Other Identifiers

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D5090C00018

Identifier Type: -

Identifier Source: org_study_id