Postherpetic Neuralgia
Conditions
Keywords
Postherpetic neuralgia, Varicella Zoster, Shingles, Neuropathic pain, Analgesia, Pain
Brief summary
The purpose of this study is to evaluate the safety and efficacy of T-62 in subjects with postherpetic neuralgia.
Detailed description
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.
Interventions
DRUGT-62 Dose 1
Capsule dosage form 100 mg bid
DRUGT-62 Dose 2
Capsule dosage form 200 mg bid
OTHERPlacebo
Capsule dosage form placebo bid
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(additional criteria apply): 1. Diagnosis of PHN made by primary treating physician and is experiencing pain for at least 3 months after the healing of a herpes zoster rash. 2. Subject is in general good health. 3. Females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control or be surgically sterile or post-menopausal. Double barrier methods and abstinence are the only acceptable birth control methods for this study.
Exclusion criteria
(additional criteria apply): 1. Subject has a current acute disease or unstable chronic disease other than post herpetic neuralgia. 2. Subject has a clinically important history of a medical disorder (particularly cardiovascular, neurological \[e.g., diabetic neuropathy\], respiratory, or hepato-biliary systems \[e.g., Gilbert Syndrome\]) that would confound and/or interfere with the safety and efficacy evaluations defined in the protocol. 3. Subject is being treated for a medical condition that affects cardiac conduction. 4. Subject's plasma alanine aminotransferase (ALT) aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase (AP) values are not within the normal reference ranges. 5. Subject has a history of asthma requiring management for reactive airway disease in the last year. 6. Subject uses and is unwilling/unable to discontinue use of (A) Lyrica® (pregabalin), Cymbalta® (duloxetine), Neurontin® (gabapentin), topical lidocaine, topical capsaicin, or other medication specifically indicated (i.e., labeled) for the treatment of neuropathic pain, or (B) anticonvulsant medications to control post herpetic neuralgia. 7. Subject currently requires anticonvulsant medications to control seizures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain scores from baseline to following treatment. | weekly |
Secondary
| Measure | Time frame |
|---|---|
| General safety monitoring (adverse reactions, vital signs, electrocardiograms, clinical laboratories) | weekly |
| Pharmacokinetics | weekly |
Countries
United States
Outcome results
None listed