A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak
- Conditions
- Postherpetic Neuralgia
- Registration Number
- NCT00506610
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale) During each Treatment Phase Visit Various pain related assessment During each Treatment Phase Visit Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores At each Treatment Phase Visit
- Secondary Outcome Measures
Name Time Method Incidence, intensity, relationship, and seriousness of treatment-emergent AEs by dose and by treatment group. Treatment-emergent changes in safety assessments Evaluation of T-62 plasma concentrations At various timepoints during the study
Trial Locations
- Locations (8)
Plains Medical Clinic
🇺🇸Fargo, North Dakota, United States
Odyssey Research
🇺🇸Spokane, Washington, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
The Center for Clinical Research
🇺🇸Winston Salem, North Carolina, United States
Anchor Research Center
🇺🇸Naples, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Crescent Moon Research
🇺🇸Murrells Inlet, South Carolina, United States