Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-609… (NCT01564459) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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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…
What they're measuring
1
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)
2
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)
3
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)