The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)
Postherpetic Neuralgia
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
Eligibility Criteria
Inclusion Criteria:
- non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment
- female is postmenopausal or surgically sterile
- has a clinical diagnosis of PHN with allodynia for at least 3 months duration after healing of rash
- has a body mass index (BMI) =< 35 kg/m^2, inclusive
- is in good health, with exception of PHN
- is on a stable dose for at least 30 days prior to screening if taking any of the following: opioids, non-opioids, paracetomol, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, antidepressants
- is a nonsmoker or has not used nicotine or nicotine containing products for at least prior 3 months
Exclusion Criteria:
- has a non-PHN chronic pain state
- has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- has a history of malignant cancer
- has a history or presence of esophagitis
- has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
- had major surgery, donated or lost approximately 500 mL of blood within 4 weeks prior to screening
- has participated in another investigational trial within 4 weeks prior to screening
- has a history of risk factors for Torsades de Pointes, has hypokalemia or hypomagnesemia
- has a history or presence of clinically significant cardiac arrhythmia, taking substances with the target of reducing heart rate and or exercising endurance sports
- has had an injection of local anesthetics or steroids in the region affected by PHN, within 35 days prior to randomization
- anticipates using prescription and non-prescription drugs or herbal remedies during trial
- consumes excessive amounts of alcoholic or caffeinated beverages
- uses cannabis, any illicit drugs, or has a history of drug (including alcohol) abuse within 12 months of screening visit
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
MK-8291 → Placebo
Placebo → MK-8291
In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)
In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)