[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659327":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":42,"interventions":66,"overallOfficials":84,"centralContacts":31,"locations":31,"responsibleParty":88,"collaborators":31,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":31,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":31,"overallStatus":109,"whyStopped":31,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":31},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Sum of the Pain Intensity Difference 0 to 48 Hours (SPID48)","The Sum of the Pain Intensity Difference (SPID) scale quantifies cumulative pain reduction to measure how effectively a pain medication or treatment works over a specific period of time. Pain is assessed by the participant using the Numeric Pain Rating Scale (NPRS) Brief Pain Inventory-Short Form (BPI-SF) \"Pain Now\" Item, which is a single item questionnaire asking the participant to rate their \"pain now\" using the numeric rating scale (0= No pain; 10= pain as bad as you can imagine; a higher score indicates more pain). The current pain score is subtracted from the baseline score at regular intervals at which pain is assessed to find the \"Pain Intensity Difference\". These differences are multiplied by the time interval and added together to yield the SPID. A higher SPID score indicates that a participant experienced more significant, cumulative pain relief during the study window. The least squares (LS) means and standard error will be provided for each treatment group.","Up to approximately 48 hours",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Number of Participants Who Experience 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 that experience AEs will be reported.","Up to approximately 16 days",{"measure":19,"description":20,"timeFrame":12},"Number of Participants Who Discontinue Study Intervention 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 that discontinue study intervention due to an AE will be reported.",{"measure":22,"description":23,"timeFrame":24},"Time to ≥2-Point Improvement on the Numeric Pain Rating Scale (NPRS) Brief Pain Inventory-Short Form (BPI-SF) \"Pain Now\" Single Item Questionnaire","The NPRS BPI-SF \"Pain Now\" Item is a single item questionnaire asking the participant to rate their \"pain now\" using the numeric rating scale (0= No pain; 10= pain as bad as you can imagine; a higer score indicates more pain). Pain is assessed by the participant using the NPRS BPI-SF \"Pain Now\" Item. Participants are assessed at baseline, and before each dose of study intervention and rescue medication. The time to ≥2-point improvement on the NPRS BPI-SF \"Pain Now\" Item is defined as the time, in minutes, from baseline to the time to ≥2 point reduction in pain intensity as measured by the NPRS BPI-SF \"Pain Now\" single item questionnaire, as estimated by the Kaplan-Meier method for each treatment group.","Baseline and up to approximately 48 hours",{"measure":26,"description":27,"timeFrame":12},"Total Amount of Opioid Rescue Medication Used (mg) from 0 to 48 Hours","The total amount of opioid rescue medications used from 0 to 48 hours will be expressed as total milligrams (mg) of opioid rescue medications administered from 0 to 48 hours. Per protocol, the stratified Wilcoxon rank-sum test, stratified by baseline NPRS, will be performed to compare MK-6916 and placebo.",{"measure":29,"description":30,"timeFrame":12},"Percentage of Participants who used any Opioid Rescue Medications from 0 to 48 hours","The percentage of participants who used any opioid rescue medication will be compared between MK-6916 and placebo, using the stratified Miettinen and Nurminen method, with baseline NPRS as the stratification factor.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":38},"TRIPLE",[39,40,41],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[43,50,54,60],{"label":44,"type":45,"description":46,"interventionNames":47},"Arm 1: MK-6916 120 milligrams (mg)","EXPERIMENTAL","Participants will receive MK-6916 120 mg every 12 hours (q12h) for 48 hours. Participants may receive rescue medication every 6 hours (q6h). Participants will be encouraged to refrain from receiving rescue medication during the first 90 minutes after the first dose of study intervention.",[48,49],"Drug: MK-6916","Drug: Rescue Medication",{"label":51,"type":45,"description":52,"interventionNames":53},"Arm 2: MK-6916 70 mg","Participants will receive MK-6916 70 mg every 12 hours (q12h) for 48 hours. Participants may receive rescue medication every 6 hours (q6h). Participants will be encouraged to refrain from receiving rescue medication during the first 90 minutes after the first dose of study intervention.",[48,49],{"label":55,"type":56,"description":57,"interventionNames":58},"Arm 3: hydrocodone 5 mg \u002Facetaminophen 325 mg (HB\u002FAPAP)","ACTIVE_COMPARATOR","Participants will receive hydrocodone 5 mg\u002Facetaminophen 325 mg (HB\u002FAPAP) every 6 hours (q6h) for 48 hours. Participants may receive rescue medication q6h. Participants will be encouraged to refrain from receiving rescue medication during the first 90 minutes after the first dose of study intervention.",[59,49],"Drug: Hydrocodone\u002Facetaminophen (HB\u002FAPAP)",{"label":61,"type":62,"description":63,"interventionNames":64},"Arm 4: MK-6916 Placebo","PLACEBO_COMPARATOR","Participants will receive MK-6916 placebo every 6 hours (q6h). Participants may receive rescue medication q6h for 48 hours. Participants will be encouraged to refrain from receiving rescue medication during the first 90 minutes after the first dose of study intervention.",[65,49],"Drug: MK-6916 Placebo",[67,72,76,80],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":31},"DRUG","MK-6916","120 mg or 70 mg oral tablet given every 12 hours (q12h) for 48 hours.",[44,51],{"type":68,"name":73,"description":74,"armGroupLabels":75,"otherNames":31},"Hydrocodone\u002Facetaminophen (HB\u002FAPAP)","Hydrocodone 5 mg\u002Facetaminophen 325 mg given as oral capsule every 6 hours (q6h) for 48 hours.",[55],{"type":68,"name":77,"description":78,"armGroupLabels":79,"otherNames":31},"MK-6916 Placebo","Placebo oral table given every 6 hours (q6h) for 48 hours",[61],{"type":68,"name":81,"description":82,"armGroupLabels":83,"otherNames":31},"Rescue Medication","Participants requesting rescue medication may receive protocol-specified rescue medication. Rescue treatment consists of open-label oxycodone immediate release (IR) oral tablet 5 mg given every 6 hours (q6h) (given in 5 mg increments for a maximum dose of 10 mg q6h). Participants should be encouraged to wait 1 hour after administration of the first dose of oxycodone 5 mg before administering a second dose. Participants will be encouraged to refrain from receiving rescue medication during the first 90 minutes after the first dose of study intervention.",[44,51,55,61],[85],{"name":86,"affiliation":5,"role":87},"Medical Director","STUDY_DIRECTOR",{"type":89,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100659327","phase-2-a-clinical-trial-of-mk-6916-in-participants-with-pain-after-bunion-removal-surgery-mk-6916-007-100659327",false,"NCT07862595","A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)","A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Analgesic Effects and Safety of MK-6916 for Acute Pain Following Bunionectomy","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a bunion and is scheduled to undergo a primary, unilateral bunionectomy that includes distal first metatarsal osteotomy (ie, Austin procedure) with internal fixation\n* Has a body mass index (BMI) of 18 to \\\u003C40 kg\u002Fm\\^2\n* Reports moderate or severe pain on the Pain Severity (Verbal Rating Scale) VRS and reports a pain score of ≥4 on the Numeric Pain Rating Scale (NPRS) (Brief Pain Inventory-Short Form \\[BPI-SF\\] \"Pain Now\" Item), within 2 to 9 hours of popliteal block discontinuation\n* Has bunionectomy under regional anesthesia using a Mayo block, popliteal sciatic block and monitored anesthesia care (MAC)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any of the following conditions in the index joint:\n* Has a Type 3 deformity requiring a base wedge osteotomy\n* Requires a concomitant surgery such as hammertoe repair or arthrodesis (fusion of the index toe)\n* Has had a prior bunionectomy or other foot surgery on the index foot\n* Has a painful, comorbid condition in the index joint, such as arthritis, that could confound the participant's assessment of postsurgical pain\n* Has an acute or chronic painful physical condition, surgical history, or sensory abnormality that may confound the ability of the participant to assess postoperative pain in the index joint\n* Has a cardiac dysrhythmia (eg, atrial fibrillation), or known structural heart disease (eg, cardiomyopathy)\n* Has a personal history of Brugada syndrome or 2 or more unexplained syncopal events\n* Has a known first degree relative with 2 or more unexplained syncopal events, unexplained cardiac arrest, sudden cardiac death or Brugada syndrome\n* Has a diagnosis of sleep apnea or uses a home continuous positive airway pressure machine\n* Has a history of peptic ulcer disease or gastrointestinal bleeding\n* Has a history of allergy or adverse reaction to opioid(s), acetaminophen (APAP), midazolam, volatile anesthetics, propofol, rocuronium, vecuronium, sugammadex, lidocaine, ondansetron, and\u002For promethazine\n* Has a history of hepatitis or liver disease that has been active within the 12 months\n* Has a history of malignancy, ≤ 3 years prior, except for successfully treated nonmelanoma skin cancer, prostate cancer, or localized carcinoma in situ of the cervix","ALL","18 Years","75 Years",{"count":101,"type":102},380,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","Researchers are looking for new treatments for pain. While there are many approved treatments for pain, the treatments do not work well for everyone. People can also become addicted to certain pain medicines. Researchers designed a trial medicine called MK-6916 to treat pain.\n\nThe goal of the trial is to learn if at least 1 dose of MK-6916 works better than placebo to lessen pain. A placebo looks like the trial medicine but has no trial medicine in it. Using a placebo helps researchers better understand the effects of the trial medicine.",[108],"Pain Management","NOT_YET_RECRUITING","2026-10-02",{"date":112,"type":113},"2026-10-07","ACTUAL",{"date":115,"type":102},"2026-11-23",{"date":117,"type":102},"2027-06-10",{"name":5,"class":6}]