The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)

NCT ID: NCT02336555

Last Updated: 2019-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-12
• Study Completion Date: 2016-02-29

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.

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-8291 → Placebo

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)

Group Type: EXPERIMENTAL

MK-8291

Intervention Type: DRUG

MK-8291 oral tablets

Placebo

Intervention Type: DRUG

Placebo oral tablets

Placebo → MK-8291

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)

Group Type: EXPERIMENTAL

MK-8291

Intervention Type: DRUG

MK-8291 oral tablets

Placebo

Intervention Type: DRUG

Placebo oral tablets

Interventions

MK-8291

MK-8291 oral tablets

Intervention Type: DRUG

Placebo

Placebo oral tablets

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Countries

Bulgaria; Georgia; Moldova; Romania

Other Identifiers

2014-002396-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-8291-012

Identifier Type: OTHER

Identifier Source: secondary_id

8291-012

Identifier Type: -

Identifier Source: org_study_id