The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Capsule dosage form 100 mg bid
Capsule dosage form 200 mg bid
Capsule dosage form placebo bid
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Westlake Village, California, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Change in pain scores from baseline to following treatment.
Time frame: weekly
General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories)
Time frame: weekly
Pharmacokinetics
Time frame: weekly
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Naples, Florida, United States
Unnamed facility
New Port Richey, Florida, United States
Unnamed facility
Sunrise, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Winston-Salem, North Carolina, United States
...and 3 more locations