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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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