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

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ClinicalTrials.gov Identifier: NCT01564459
Recruitment Status : Completed
First Posted : March 27, 2012
Results First Posted : August 10, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Interventions Drug: MK-6096
Drug: Placebo
Enrollment 170
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-6096 10 mg→No Treatment MK-6096 10 mg→MK-6096 10 mg MK-6096 10 mg→Placebo
Hide Arm/Group Description Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period. 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. Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
Period Title: Run-In
Started 12 87 [1] 83 [1]
Completed 0 87 83
Not Completed 12 0 0
Reason Not Completed
Adverse Event             7             0             0
Lost to Follow-up             1             0             0
Non-compliance with study drug             2             0             0
Protocol Violation             1             0             0
Withdrawal by Subject             1             0             0
[1]
1 participant randomized to placebo arm received MK-6096 10 mg
Period Title: Double-blind Treatment
Started 0 87 [1] 83 [1]
Completed 0 87 82
Not Completed 0 0 1
Reason Not Completed
Adverse Event             0             0             1
[1]
1 participant randomized to placebo arm received MK-6096 10 mg
Arm/Group Title MK-6096 10 mg→No Treatment MK-6096 10 mg→MK-6096 10 mg MK-6096 10 mg→Placebo Total
Hide Arm/Group Description Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period. 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 Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period. Total of all reporting groups
Overall Number of Baseline Participants 12 87 83 182
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 87 participants 83 participants 182 participants
54.8  (6.9) 55.6  (9.2) 55.5  (10.3) 55.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 87 participants 83 participants 182 participants
Female
7
  58.3%
38
  43.7%
36
  43.4%
81
  44.5%
Male
5
  41.7%
49
  56.3%
47
  56.6%
101
  55.5%
1.Primary Outcome
Title Time to Efficacy Failure (TTEF) - Primary Responders
Hide Description 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.
Time Frame Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.
Arm/Group Title MK-6096 Placebo
Hide Arm/Group Description:
Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
Matching compressed tablets, taken once daily at bedtime for 14 days.
Overall Number of Participants Analyzed 37 28
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
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).
2.Primary Outcome
Title Percentage of Participants Who Experienced 1 or More Adverse Events (AE)
Hide Description 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.
Time Frame up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Hide Arm/Group Description:
Participants who received MK-6096 10 mg during run-in period
Participants who received MK-6096 during double blind treatment period
Participants who received placebo during double-blind treatment period
Overall Number of Participants Analyzed 182 88 82
Measure Type: Number
Unit of Measure: Percentage of Participants
24.7 23.9 13.4
3.Primary Outcome
Title Percentage of Participants Who Were Discontinued Form the Study Due to an AE
Hide Description 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.
Time Frame up to 7 days for run-in; up to 14 days for active treatment period)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Hide Arm/Group Description:
Participants who received MK-6096 10 mg during run-in period
Participants who received MK-6096 during double blind treatment period
Participants who received placebo during double-blind treatment period
Overall Number of Participants Analyzed 182 88 82
Measure Type: Number
Unit of Measure: Percentage of Participants
3.8 0.0 1.2
4.Secondary Outcome
Title TTEF - All Responders
Hide Description 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.
Time Frame Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants (continued into double-blind treatment period) who met criteria as a responder.
Arm/Group Title MK-6096 Placebo
Hide Arm/Group Description:
MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
Matching compressed tablets, taken once daily at bedtime for 14 days.
Overall Number of Participants Analyzed 47 41
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
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).
5.Secondary Outcome
Title Change in Pain Intensity Scores - Primary Responders
Hide Description 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.
Time Frame End of Single-Blind Period (Baseline) and end of Double-Blind Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.
Arm/Group Title MK-6096 Placebo
Hide Arm/Group Description:
MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
Matching compressed tablets, taken once daily at bedtime for 14 days.
Overall Number of Participants Analyzed 37 28
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
-0.104
(-0.821 to 0.612)
0.482
(-0.332 to 1.297)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-6096, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments [Not Specified]
Method Constrained longitudinal data analysis
Comments terms for treatment, time and treatment-by-time interaction
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -0.587
Confidence Interval (2-Sided) 95%
-1.637 to 0.464
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Pain Intensity Scores - All Responders
Hide Description 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.
Time Frame End of Single-Blind Period (Baseline) and end of Double-Blind Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants (continued into double-blind treatment period) who met criteria as a responder.
Arm/Group Title MK-6096 Placebo
Hide Arm/Group Description:
MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
Matching compressed tablets, taken once daily at bedtime for 14 days.
Overall Number of Participants Analyzed 47 41
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-0.318
(-0.917 to 0.281)
0.368
(-0.268 to 1.004)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-6096, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Constrained longitudinal data analysis
Comments terms for treatment, time and treatment-by-time interaction
Method of Estimation Estimation Parameter Difference in Least Squares Means
Estimated Value -0.687
Confidence Interval (2-Sided) 95%
-1.527 to 0.154
Estimation Comments [Not Specified]
Time Frame up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)
Adverse Event Reporting Description 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.
 
Arm/Group Title MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Hide Arm/Group Description Participants who received MK-6096 10 mg during run-in period Participants who received MK-6096 during double blind treatment period Participants who received placebo during double-blind treatment period
All-Cause Mortality
MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/182 (1.65%)      0/88 (0.00%)      1/82 (1.22%)    
Cardiac disorders       
Acute myocardial infarction  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Cardio-respiratory arrest  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Gastrointestinal disorders       
Upper gastrointestinal haemorrhage  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
General disorders       
Chest pain  1  0/182 (0.00%)  0 0/88 (0.00%)  0 1/82 (1.22%)  1
Infections and infestations       
Sepsis syndrome  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Nervous system disorders       
Encephalopathy  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Syncope  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Renal and urinary disorders       
Renal failure acute  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Vascular disorders       
Blood pressure inadequately controlled  1  1/182 (0.55%)  1 0/88 (0.00%)  0 0/82 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-6096 10 mg - Run-in Period MK-6096 10 Mg-Double Blind Period Placebo- Double-Blind Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/182 (0.00%)      0/88 (0.00%)      0/82 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01564459     History of Changes
Other Study ID Numbers: 6096-021
First Submitted: February 28, 2012
First Posted: March 27, 2012
Results First Submitted: May 2, 2016
Results First Posted: August 10, 2016
Last Update Posted: November 7, 2018