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MK-6916 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Arm 2: MK-6916 70 mg | EXPERIMENTAL | 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. |
| Arm 3: hydrocodone 5 mg /acetaminophen 325 mg (HB/APAP) | ACTIVE_COMPARATOR | Participants will receive hydrocodone 5 mg/acetaminophen 325 mg (HB/APAP) 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| MK-6916 | DRUG | 120 mg or 70 mg oral tablet given every 12 hours (q12h) for 48 hours. |
| Hydrocodone/acetaminophen (HB/APAP) | DRUG | Hydrocodone 5 mg/acetaminophen 325 mg given as oral capsule every 6 hours (q6h) for 48 hours. |
| MK-6916 Placebo | DRUG | Placebo oral table given every 6 hours (q6h) for 48 hours |
| Rescue Medication | DRUG | 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. |
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...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viking Therapeutics, Inc. | VKTX | 4 | PHASE3 | VK2735 |
| Structure Therapeutics, Inc. Sponsored ADR | GPCR | 1 | PHASE2 | Aleniglipron |
MK-6916 is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for pain management. It is currently in Phase 2 clinical development and has not been approved by the FDA. The program is evaluating the drug in patients experiencing pain following bunion removal surgery.
MK-6916 is being studied for pain management, specifically in patients with pain after bunion removal surgery. It is an investigational therapy in Phase 2 development and is not approved for any indication. The clinical program is designed to assess its potential in treating acute post-surgical pain.
MK-6916 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in pain management, including the Phase 2 trial in patients recovering from bunion removal surgery.
MK-6916 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The ongoing Phase 2 study is evaluating the drug in patients with pain after bunion removal surgery.
MK-6916 is being evaluated in one Phase 2 clinical trial, NCT07862595, titled A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007). The trial is not yet recruiting, plans to enroll 380 participants aged 18 years and older, and is randomized, double-blind, and placebo-controlled.