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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01564459
First received: February 28, 2012
Last updated: June 27, 2016
Last verified: June 2016
Results First Received: May 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetic Neuropathy, Painful
Interventions: Drug: MK-6096
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Run-In
    MK-6096 10 mg→No Treatment   MK-6096 10 mg→MK-6096 10 mg   MK-6096 10 mg→Placebo
STARTED   12   87 [1]   83 [1] 
COMPLETED   0   87   83 
NOT COMPLETED   12   0   0 
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 2:   Double-blind Treatment
    MK-6096 10 mg→No Treatment   MK-6096 10 mg→MK-6096 10 mg   MK-6096 10 mg→Placebo
STARTED   0   87 [1]   83 [1] 
COMPLETED   0   87   82 
NOT COMPLETED   0   0   1 
Adverse Event                0                0                1 
[1] 1 participant randomized to placebo arm received MK-6096 10 mg



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   MK-6096 10 mg→No Treatment   MK-6096 10 mg→MK-6096 10 mg   MK-6096 10 mg→Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   87   83   182 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.8  (6.9)   55.6  (9.2)   55.5  (10.3)   55.5  (9.5) 
Gender 
[Units: Participants]
       
Female   7   38   36   81 
Male   5   49   47   101 


  Outcome Measures
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1.  Primary:   Time to Efficacy Failure (TTEF) - Primary Responders   [ Time Frame: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days) ]

2.  Primary:   Percentage of Participants Who Experienced 1 or More Adverse Events (AE)   [ Time Frame: up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period) ]

3.  Primary:   Percentage of Participants Who Were Discontinued Form the Study Due to an AE   [ Time Frame: up to 7 days for run-in; up to 14 days for active treatment period) ]

4.  Secondary:   TTEF - All Responders   [ Time Frame: Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days) ]

5.  Secondary:   Change in Pain Intensity Scores - Primary Responders   [ Time Frame: End of Single-Blind Period (Baseline) and end of Double-Blind Period ]

6.  Secondary:   Change in Pain Intensity Scores - All Responders   [ Time Frame: End of Single-Blind Period (Baseline) and end of Double-Blind Period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01564459     History of Changes
Other Study ID Numbers: 6096-021
Study First Received: February 28, 2012
Results First Received: May 2, 2016
Last Updated: June 27, 2016
Health Authority: United States: Food and Drug Administration