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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Bradenton Research Center
Bradenton, Florida, United States
Anchor Research Center
Naples, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Pain Intensity Difference (PID) scores (derived from data obtained using the 11 point Likert pain rating scale)
Time frame: During each Treatment Phase Visit
Various pain related assessment
Time frame: During each Treatment Phase Visit
Clinical Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC ) scores
Time frame: At each Treatment Phase Visit
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
Time frame: At various timepoints during the study
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Plains Medical Clinic
Fargo, North Dakota, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Crescent Moon Research
Murrells Inlet, South Carolina, United States
Odyssey Research
Spokane, Washington, United States