CompletedPhase 2

Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)

170 participantsStarted 2012-03-26

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of MK-6096 in the treatment of painful diabetic neuropathy (PDN) in adults.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has a primary diagnosis of painful diabetic neuropathy (PDN) for at least 6 months. * Is able to understand \& use an electronic diary to complete daily questionnaires. * If female of reproductive potential, agrees to use acceptable contraception from Screening through to at least 2 weeks after last dose of study drug. * Is on a stable dose of antihyperglycemic treatment for at least 1 month, with hemoglobin A1C level of no more than 11%. * If taking an allowable around-the-clock medication for chronic pain, has been on a stable dose for at least 1 month \& agrees to stay on same dose during the study. * Agrees to not start therapy with opioids, pregabalin, gabapentin, duloxetine or any other medications used to treat neuropathic pain during the study. * Has a regular bedtime of before 1 AM (01:00). * Agrees to limit alcohol consumption to no more than 3 drinks a day, with no drinks within 3 hours before bedtime. One drink is defined as: 1) 12 ounces of beer; 2) 4 ounces of wine; or 3) 1 ounce of liquor (80 proof or 40% alcohol). * Agrees to limit caffeine consumption to no more than 5 standard 6-oz. cups of caffeinated beverages or no more than 600 mg caffeine a day, with no caffeinated beverages after 4 PM (16:00). * Agrees to maintain a relatively consistent level of activity throughout the study. Exclusion Criteria: * Is pregnant or breastfeeding, or expects to become pregnant during the study. * Expects to donate eggs or sperm during the study or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Efficacy Failure (TTEF) - Primary Responders

Timeframe: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)

Percentage of Participants Who Experienced 1 or More Adverse Events (AE)

Timeframe: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)

Percentage of Participants Who Were Discontinued Form the Study Due to an AE

Timeframe: up to 7 days for run-in; up to 14 days for active treatment period)

Trial details

NCT IDNCT01564459

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04-18

Results submitted2016-05-02

View on ClinicalTrials.gov More Diabetic Neuropathy, Painful trials