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

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Postherpetic Neuralgia

Treatments

Drug: T-62

Study type

Interventional

Funder types

Industry

Identifiers

NCT00506610

K862-06-2001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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