Clinical trial NCT02336555: The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)
Official title: A Randomized Clinical Trial to Study the Efficacy, Safety, and Tolerability of MK-8291 in Subjects With Post-Herpetic Neuralgia With Allodynia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postherpetic Neuralgia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.

The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.


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

Primary outcomes:
measure: Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period
timeFrame: Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)
Secondary outcomes:
measure: Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity
timeFrame: Baseline and Day 28 in each treatment period (Up to approximately 63 days)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: