A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

NCT ID: NCT00506610

Last Updated: 2012-06-07

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.

Detailed Description

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Conditions

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Postherpetic Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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T-62

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
* Experiencing pain for at least 3 months after the healing of shingles rash
* Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
* Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
* Will not consume grapefruit or grapefruit juice during the study

Exclusion Criteria

* Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
* Has clinically important medical disorder
* Uses certain types of medications for heart conditions
* Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
* Has a history of hypersensitivity to any medication or soy product
* Has liver or kidney disease
* Has asthma that required treatment within the last year
* Has HIV or hepatitis (other than hepatitis A)
* Has a history of alcohol abuse within the past 2 years
* Has a history of (within last 2 years) or currently abuses prescription or illegal drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Locations

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Bradenton Research Center

Bradenton, Florida, United States

Site Status

Anchor Research Center

Naples, Florida, United States

Site Status

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status

Plains Medical Clinic

Fargo, North Dakota, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Crescent Moon Research

Murrells Inlet, South Carolina, United States

Site Status

Odyssey Research

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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K862-06-2001

Identifier Type: -

Identifier Source: org_study_id

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