Trial Outcomes & Findings for Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021) (NCT NCT01564459)
NCT ID: NCT01564459
Last Updated: 2018-11-07
Results Overview
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.
COMPLETED
PHASE2
170 participants
Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
2018-11-07
Participant Flow
Participant milestones
| Measure |
MK-6096 10 mg→No Treatment
Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
|
MK-6096 10 mg→MK-6096 10 mg
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
|
MK-6096 10 mg→Placebo
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
|
|---|---|---|---|
|
Run-In
STARTED
|
12
|
87
|
83
|
|
Run-In
COMPLETED
|
0
|
87
|
83
|
|
Run-In
NOT COMPLETED
|
12
|
0
|
0
|
|
Double-blind Treatment
STARTED
|
0
|
87
|
83
|
|
Double-blind Treatment
COMPLETED
|
0
|
87
|
82
|
|
Double-blind Treatment
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
MK-6096 10 mg→No Treatment
Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
|
MK-6096 10 mg→MK-6096 10 mg
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
|
MK-6096 10 mg→Placebo
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
|
|---|---|---|---|
|
Run-In
Adverse Event
|
7
|
0
|
0
|
|
Run-In
Lost to Follow-up
|
1
|
0
|
0
|
|
Run-In
Non-compliance with study drug
|
2
|
0
|
0
|
|
Run-In
Protocol Violation
|
1
|
0
|
0
|
|
Run-In
Withdrawal by Subject
|
1
|
0
|
0
|
|
Double-blind Treatment
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Study to Evaluate MK-6096 in the Treatment of Painful Diabetic Neuropathy (PDN) in Adults (MK-6096-021)
Baseline characteristics by cohort
| Measure |
MK-6096 10 mg→No Treatment
n=12 Participants
Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
|
MK-6096 10 mg→MK-6096 10 mg
n=87 Participants
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
|
MK-6096 10 mg→Placebo
n=83 Participants
Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)Population: All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.
Outcome measures
| Measure |
MK-6096
n=37 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=28 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Time to Efficacy Failure (TTEF) - Primary Responders
|
NA Days
Estimate of median time to efficacy failure is Not Available due to \<50% of participants with documented efficacy failure (causing the median to be non-estimable).
|
NA Days
Estimate of median time to efficacy failure is Not Available due to \<50% of participants with documented efficacy failure (causing the median to be non-estimable).
|
—
|
PRIMARY outcome
Timeframe: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)Population: All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.
Outcome measures
| Measure |
MK-6096
n=182 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=88 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
n=82 Participants
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Percentage of Participants Who Experienced 1 or More Adverse Events (AE)
|
24.7 Percentage of Participants
|
23.9 Percentage of Participants
|
13.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 7 days for run-in; up to 14 days for active treatment period)Population: All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.
Outcome measures
| Measure |
MK-6096
n=182 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=88 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
n=82 Participants
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Percentage of Participants Who Were Discontinued Form the Study Due to an AE
|
3.8 Percentage of Participants
|
0.0 Percentage of Participants
|
1.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)Population: All randomized participants (continued into double-blind treatment period) who met criteria as a responder.
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.
Outcome measures
| Measure |
MK-6096
n=47 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=41 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
TTEF - All Responders
|
NA Days
Estimate of median time to efficacy failure is Not Available due to \<50% of participants with documented efficacy failure (causing the median to be non-estimable).
|
NA Days
Estimate of median time to efficacy failure is Not Available due to \<50% of participants with documented efficacy failure (causing the median to be non-estimable).
|
—
|
SECONDARY outcome
Timeframe: End of Single-Blind Period (Baseline) and end of Double-Blind PeriodPopulation: All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.
Outcome measures
| Measure |
MK-6096
n=37 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=28 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Change in Pain Intensity Scores - Primary Responders
|
-0.104 Score on a Scale
Interval -0.821 to 0.612
|
0.482 Score on a Scale
Interval -0.332 to 1.297
|
—
|
SECONDARY outcome
Timeframe: End of Single-Blind Period (Baseline) and end of Double-Blind PeriodPopulation: All randomized participants (continued into double-blind treatment period) who met criteria as a responder.
Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.
Outcome measures
| Measure |
MK-6096
n=47 Participants
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
|
Placebo
n=41 Participants
Matching compressed tablets, taken once daily at bedtime for 14 days.
|
Placebo- Double-Blind Period
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Change in Pain Intensity Scores - All Responders
|
-0.318 Score on a scale
Interval -0.917 to 0.281
|
0.368 Score on a scale
Interval -0.268 to 1.004
|
—
|
Adverse Events
MK-6096 10 mg - Run-in Period
MK-6096 10 Mg-Double Blind Period
Placebo- Double-Blind Period
Serious adverse events
| Measure |
MK-6096 10 mg - Run-in Period
n=182 participants at risk
Participants who received MK-6096 10 mg during run-in period
|
MK-6096 10 Mg-Double Blind Period
n=88 participants at risk
Participants who received MK-6096 during double blind treatment period
|
Placebo- Double-Blind Period
n=82 participants at risk
Participants who received placebo during double-blind treatment period
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Infections and infestations
Sepsis syndrome
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Nervous system disorders
Encephalopathy
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Nervous system disorders
Syncope
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Renal and urinary disorders
Renal failure acute
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.55%
1/182 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/82 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
|
General disorders
Chest pain
|
0.00%
0/182 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
0.00%
0/88 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
1.2%
1/82 • Number of events 1 • up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER