Postherpetic Neuralgia
Conditions
Keywords
Pain, Postherpetic Neuralgia, Neuralgia, Postherpetic, Shingles, Herpes Zoster, Neuropathic Pain
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.
Interventions
DRUGT-62
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed