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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6096 10 mg→MK-6096 10 mg | Experimental | Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive MK-6096 10 mg once daily for 2 weeks during double-blind treatment period. |
|
| MK-6096→Placebo | Placebo Comparator | Participants receive MK-6096 10 mg during run-in once daily for 1 week and receive placebo once daily for 2 weeks during double-blind treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6096 | Drug | MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Efficacy Failure (TTEF) - Primary Responders | 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. | 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) | 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. | 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 | 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. | up to 7 days for run-in; up to 14 days for active treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| TTEF - All Responders | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28448426 | Result | Joseph Herring W, Ge JY, Jackson S, Assaid C, Connor KM, Michelson D. Orexin Receptor Antagonism in Painful Diabetic Neuropathy: A Phase 2 Trial With Filorexant. Clin J Pain. 2018 Jan;34(1):37-43. doi: 10.1097/AJP.0000000000000503. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In |
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| |||||||||||||||||||||
| Double-blind Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Efficacy Failure (TTEF) - Primary Responders | 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. | All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder. | Posted | Median | 95% Confidence Interval | Days | Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-6096 10 mg - Run-in Period | Participants who received MK-6096 10 mg during run-in period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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| ID | Term |
|---|---|
| C573816 | MK-6096 |
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| Placebo | Drug | Matching compressed tablets, taken once daily at bedtime for 14 days. |
|
| Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days) |
| Change in Pain Intensity Scores - Primary Responders | 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. | End of Single-Blind Period (Baseline) and end of Double-Blind Period |
| Change in Pain Intensity Scores - All Responders | 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. | End of Single-Blind Period (Baseline) and end of Double-Blind Period |
| Non-compliance with study drug |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG000 | MK-6096 | Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period. |
| OG001 | Placebo | Matching compressed tablets, taken once daily at bedtime for 14 days. |
|
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| Secondary | TTEF - All Responders | 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. | All randomized participants (continued into double-blind treatment period) who met criteria as a responder. | Posted | Median | 95% Confidence Interval | Days | Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days) |
|
|
|
| Secondary | Change in Pain Intensity Scores - Primary Responders | 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. | All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a Scale | End of Single-Blind Period (Baseline) and end of Double-Blind Period |
|
|
|
|
| Secondary | Change in Pain Intensity Scores - All Responders | 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. | All randomized participants (continued into double-blind treatment period) who met criteria as a responder. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | End of Single-Blind Period (Baseline) and end of Double-Blind Period |
|
|
|
|
| Primary | Percentage of Participants Who Experienced 1 or More Adverse Events (AE) | 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. | 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. | Posted | Number | Percentage of Participants | up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period) |
|
|
|
| Primary | Percentage of Participants Who Were Discontinued Form the Study Due to an AE | 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. | 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. | Posted | Number | Percentage of Participants | up to 7 days for run-in; up to 14 days for active treatment period) |
|
|
|
| 3 |
| 182 |
| 0 |
| 182 |
| EG001 | MK-6096 10 Mg-Double Blind Period | Participants who received MK-6096 during double blind treatment period | 0 | 88 | 0 | 88 |
| EG002 | Placebo- Double-Blind Period | Participants who received placebo during double-blind treatment period | 1 | 82 | 0 | 82 |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 16.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
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| Sepsis syndrome | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 16.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA version 16.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
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| Blood pressure inadequately controlled | Vascular disorders | MedDRA version 16.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 16.0 | Systematic Assessment |
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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.
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |