Merck Sharp & Dohme LLC
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.
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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/m\^2 * 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 bunio…
120 mg or 70 mg oral tablet given every 12 hours (q12h) for 48 hours.
Hydrocodone 5 mg/acetaminophen 325 mg given as oral capsule every 6 hours (q6h) for 48 hours.
Placebo oral table given every 6 hours (q6h) for 48 hours
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.