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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4305-085 | Other Identifier | MSD | |
| jRCT2031200149 | Registry Identifier | jRCT |
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The goal of this study is to evaluate the efficacy and safety of suvorexant (MK-4305) for reducing the incidence of delirium in Japanese participants who are at high risk of delirium. The primary hypothesis is that suvorexant reduces the proportion of participants with delirium compared with placebo as assessed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suvorexant | Experimental | Participants will receive 15 mg of suvorexant orally once daily (QD) for 5 to 7 days. |
|
| Placebo | Placebo Comparator | Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | Suvorexant administered at a dose of 15 mg QD via oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria | The DSM-5 is the gold standard for the diagnosis of delirium. DSM-5 criteria were used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria is presented. | Up to ~8 days |
| Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is presented. | Up to ~21 days |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented. | Up to ~7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98) | DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. The maximum daily total score on DRS-R-98 is presented. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kohnodai Hospital, National Center for Global Health and Medicine ( Site 8522) | Ichikawa | Chiba | 272-8516 | Japan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39150711 | Result | Hatta K, Kishi Y, Wada K, Takeuchi T, Taira T, Uemura K, Ogawa A, Takahashi K, Sato A, Shirakawa M, Herring WJ, Arano I; Suvorexant 085 Study Group. Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2427691. doi: 10.1001/jamanetworkopen.2024.27691. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant | Participants received 15 mg of suvorexant orally once daily (QD) for 5 to 7 days. |
| FG001 | Placebo | Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2022 |
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| Placebo | Drug | Suvorexant-matching placebo administered QD via oral tablet |
|
| Up to ~8 days |
| Percentage of Participants With Delirium as Assessed by DRS-R-98 | DRS-R-98 is a diagnostic and assessment tool used for the evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. Optimized cutoff score for delirium diagnosis in Japanese-translated DRS-R-98 has been determined as ≥14.5. The percentage of participants with delirium as assessed by DRS-R-98, defined as the percentage of participants with total score ≥14.5 per DRS-R-98, is presented. | Up to ~8 days |
| Iizuka Hospital ( Site 8540) |
| Iizuka |
| Fukuoka |
| Japan |
| Kokura Memorial Hospital ( Site 8537) | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Maebashi Red Cross Hospital ( Site 8548) | Maebashi | Gunma | 371-0811 | Japan |
| Fukuyama City Hospital ( Site 8528) | Fukuyama | Hiroshima | 721-8511 | Japan |
| Tonan Hospital ( Site 8512) | Sapporo | Hokkaido | 060-0004 | Japan |
| Kansai Rosai Hospital ( Site 8550) | Amagasaki | Hyōgo | 660-8511 | Japan |
| Kanazawa Medical University Hospital ( Site 8514) | Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| National Hospital Organization Kanazawa Medical Center ( Site 8554) | Kanazawa | Ishikawa-ken | 920-8650 | Japan |
| Kagawa University Hospital ( Site 8519) | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| TAKAMATSU Red Cross Hospital ( Site 8547) | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Nippon Medical School Musashi Kosugi Hospital ( Site 8502) | Kawasaki | Kanagawa | 211-8533 | Japan |
| Showa University Northern Yokohama Hospital ( Site 8534) | Yokohama | Kanagawa | 224-8503 | Japan |
| Yokohama City University Medical Center ( Site 8516) | Yokohama | Kanagawa | 232-0024 | Japan |
| Saiseikai Yokohamashi Nanbu Hospital ( Site 8541) | Yokohama | Kanagawa | 234-8503 | Japan |
| Yokohama City University Hospital ( Site 8515) | Yokohama | Kanagawa | 2360064 | Japan |
| National Hospital Organization Yokohama Medical Center ( Site 8531) | Yokohama | Kanagawa | 245-8575 | Japan |
| National Hospital Organization Maizuru Medical Center ( Site 8535) | Maizuru-shi | Kyoto | 625-8502 | Japan |
| Aizawa Hospital ( Site 8542) | Matsumoto | Nagano | 390-8510 | Japan |
| Matsushita Memorial Hospital ( Site 8556) | Moriguchi | Osaka | 570-8540 | Japan |
| Osaka University Hospital ( Site 8524) | Suita | Osaka | 565-0871 | Japan |
| Toyonaka Municipal Hospital ( Site 8521) | Toyonaka | Osaka | 560-8565 | Japan |
| Shimane Prefectural Central Hospital ( Site 8530) | Izumo | Shimane | 693-8555 | Japan |
| Kamitsuga General Hospital ( Site 8546) | Kanuma | Tochigi | 322-8550 | Japan |
| SANO KOSEI GENERAL HOSPITAL ( Site 8551) | Sano | Tochigi | 327-8511 | Japan |
| Jichi Medical University Hospital ( Site 8525) | Shimotsuke | Tochigi | 329-0498 | Japan |
| Yamaguchi University Hospital ( Site 8517) | Ube | Yamaguchi | 755-8505 | Japan |
| National Hospital Organization Kyushu Medical Center ( Site 8532) | Fukuoka | 810-8563 | Japan |
| Gifu Municipal Hospital ( Site 8555) | Gifu | 500-8513 | Japan |
| Hiroshima City Hiroshima Citizens Hospital ( Site 8505) | Hiroshima | 730-8518 | Japan |
| National Hospital Organization Kumamoto Medical Center ( Site 8511) | Kumamoto | 860-0008 | Japan |
| Japanese Red Cross Kyoto Daini Hospital ( Site 8533) | Kyoto | 602-8026 | Japan |
| Kyoto Katsura Hospital ( Site 8539) | Kyoto | 615-8256 | Japan |
| Miyazaki Prefectural Miyazaki Hospital ( Site 8543) | Miyazaki | 880-8510 | Japan |
| Niigata City General Hospital ( Site 8544) | Niigata | 950-1197 | Japan |
| Okayama Saiseikai General Hospital ( Site 8549) | Okayama | 700-8511 | Japan |
| Okayama University Hospital ( Site 8510) | Okayama | 7008558 | Japan |
| Osaka City General Hospital ( Site 8518) | Osaka | 534-0021 | Japan |
| National Hospital Organization Osaka National Hospital ( Site 8536) | Osaka | 540-0006 | Japan |
| Japanese Red Cross Osaka Hospital ( Site 8523) | Osaka | 543-8555 | Japan |
| Nippon Life Hospital ( Site 8552) | Osaka | 550-0006 | Japan |
| Japan Community Health care Organization Osaka Hospital ( Site 8545) | Osaka | 553-0003 | Japan |
| Osaka General Medical Center ( Site 8538) | Osaka | 558-8558 | Japan |
| Saga-Ken Medical Centre Koseikan ( Site 8526) | Saga | 840-8571 | Japan |
| Tokushima Prefectural Central Hospital ( Site 8509) | Tokushima | 770-8539 | Japan |
| National Cancer Center Hospital ( Site 8520) | Tokyo | 104-0045 | Japan |
| National Hospital Organization Tokyo Medical Center ( Site 8529) | Tokyo | 152-8902 | Japan |
| Tokyo Women's Medical University Hospital ( Site 8527) | Tokyo | 162-8666 | Japan |
| Juntendo University Nerima Hospital ( Site 8501) | Tokyo | 177-8521 | Japan |
| Tokyo Medical and Dental University Hospital ( Site 8503) | Tokyo | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant | Participants received 15 mg of suvorexant orally once daily (QD) for 5 to 7 days. |
| BG001 | Placebo | Participants will receive suvorexant-matching placebo orally QD for 5 to 7 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Delirium as Assessed by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria | The DSM-5 is the gold standard for the diagnosis of delirium. DSM-5 criteria were used for clinician assessment of delirium. The percentage of participants with delirium per DSM-5 criteria is presented. | All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment | Posted | Number | Percentage of participants | Up to ~8 days |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is presented. | All randomized participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to ~21 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is presented. | All randomized participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | Up to ~7 days |
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| Secondary | Maximum Daily Total Score on Delirium Rating Scale-Revised-98 (DRS-R-98) | DRS-R-98 is a diagnostic and assessment tool used for evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. The maximum daily total score on DRS-R-98 is presented. | All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment | Posted | Median | Inter-Quartile Range | Score on a scale | Up to ~8 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Delirium as Assessed by DRS-R-98 | DRS-R-98 is a diagnostic and assessment tool used for the evaluation of delirium. It is a 16-item clinician-rated scale with 13 items measuring delirium severity and 3 diagnostic items. The total DRS-R-98 score can range from 0 (lowest) to 46 (highest). Higher scores indicate worsening or more severe delirium. Optimized cutoff score for delirium diagnosis in Japanese-translated DRS-R-98 has been determined as ≥14.5. The percentage of participants with delirium as assessed by DRS-R-98, defined as the percentage of participants with total score ≥14.5 per DRS-R-98, is presented. | All randomized participants who had at least one assessment of delirium by DSM-5 following administration of at least one dose of study treatment | Posted | Number | Percentage of participants | Up to ~8 days |
|
|
Up to ~21 days
The safety analysis population included all randomized participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all randomized participants.
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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 | Suvorexant | Participants received 15 mg of suvorexant orally QD for 5 to 7 days. | 1 | 105 | 6 | 101 | 64 | 101 |
| EG001 | Placebo | Participants received suvorexant-matching placebo orally QD for 5 to 7 days. | 0 | 102 | 6 | 102 | 69 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Dec 12, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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