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.
The 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.
Has a bunion and is scheduled to undergo a primary, unilateral bunionectomy that includes distal first metatarsal osteotomy (ie, Austin procedure) with internal fixation
Has a body mass index (BMI) of 18 to <40 kg/m²
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
Has bunionectomy under regional anesthesia using a Mayo block, popliteal sciatic block and monitored anesthesia care (MAC)
Has a Type 3 deformity requiring a base wedge osteotomy
Requires a concomitant surgery such as hammertoe repair or arthrodesis (fusion of the index toe)
Has had a prior bunionectomy or other foot surgery on the index foot
Has a painful, comorbid condition in the index joint, such as arthritis, that could confound the participant's assessment of postsurgical pain
Parallel
MK-6916
Drug120 mg or 70 mg oral tablet given every 12 hours (q12h) for 48 hours.
Hydrocodone/acetaminophen (HB/APAP)
DrugHydrocodone 5 mg/acetaminophen 325 mg given as oral capsule every 6 hours (q6h) for 48 hours.
MK-6916 Placebo
DrugPlacebo oral table given every 6 hours (q6h) for 48 hours
Rescue Medication
DrugParticipants 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.
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.
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.
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.
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
