Pain ManagementPhase 2NCT07862595
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
A Phase 2 study testing MK-6916, Hydrocodone/acetaminophen (HB/APAP) and Rescue Medication in people with Pain Management, run by Merck Sharp & Dohme LLC at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management
- What is being tested?
- MK-6916, Hydrocodone/acetaminophen (HB/APAP) and Rescue Medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 Nov 2026to 10 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 bunionectomy under regional anesthesia using a Mayo block, popliteal sciatic block and monitored anesthesia care (MAC)
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has any of the following conditions in the index joint:
- 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
Show all 15Show fewer
- 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
- Has a cardiac dysrhythmia (eg, atrial fibrillation), or known structural heart disease (eg, cardiomyopathy)
- Has a personal history of Brugada syndrome or 2 or more unexplained syncopal events
- Has a known first degree relative with 2 or more unexplained syncopal events, unexplained cardiac arrest, sudden cardiac death or Brugada syndrome
- Has a diagnosis of sleep apnea or uses a home continuous positive airway pressure machine
- Has a history of peptic ulcer disease or gastrointestinal bleeding
- Has a history of allergy or adverse reaction to opioid(s), acetaminophen (APAP), midazolam, volatile anesthetics, propofol, rocuronium, vecuronium, sugammadex, lidocaine, ondansetron, and/or promethazine
- Has a history of hepatitis or liver disease that has been active within the 12 months
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Atlanta Center for Medical Research ( Site 0708)
Atlanta, Georgia, 30331
Study Coordinator, 404-881-5800
Legent Orthopedic & Spine Hospital ( Site 0711)
Bellaire, Texas, 77401
Study Coordinator, 713-367-8548
Memorial Hermann Village ( Site 0704)
Houston, Texas, 77043
Study Coordinator, 281-369-5765
Futuro Clinical Trials ( Site 0703)
McAllen, Texas, 78501
Study Coordinator, 956-999-8399
Clinical Pharmacology of Miami ( Site 0718)
Miami, Florida, 33172
Study Coordinator, 305-817-2900
Gateway Clinical Trails, Llc ( Site 0701)
O'Fallon, Illinois, 62269
Study Coordinator, 618-726-1160
JBR Clinical Research ( Site 0702)
Salt Lake City, Utah, 84107
Study Coordinator, 801-261-2000
Endeavor Clinical Trials PA ( Site 0700)
San Antonio, Texas, 78240
Study Coordinator, 210-503-9773
ForCare Clinical Research ( Site 0705)
Tampa, Florida, 33613
Study Coordinator, 813-264-2155
About this study
Official title: 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
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.
- Conditions
- Pain Management
- Being tested
- MK-6916, Hydrocodone/acetaminophen (HB/APAP), MK-6916 Placebo, Rescue Medication
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6916Drug
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 PlaceboDrug
Placebo oral table given every 6 hours (q6h) for 48 hours
Rescue MedicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MK-6916; Drug: Rescue Medication |
| 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. Receives: Drug: MK-6916; Drug: Rescue Medication |
| 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. Receives: Drug: Hydrocodone/acetaminophen (HB/APAP); Drug: Rescue Medication |
| 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. Receives: Drug: MK-6916 Placebo; Drug: Rescue Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 48 hours
Secondary outcomes (5)
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.
Measured: Up to approximately 16 days
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.
Measured: Up to approximately 48 hours
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.
Measured: Baseline and up to approximately 48 hours
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.
Measured: Up to approximately 48 hours
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.
Measured: Up to approximately 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start23 Nov 2026 (estimated)
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862595
- Sponsor's protocol ID
- 6916-007
- Other IDs
- MK-6916-007
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07862595
- Acronym / sponsor ID
- 6916-007
- Conditions
- Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MK-6916 120 milligrams (mg) | Experimental | Drug: MK-6916, Drug: Rescue MedicationParticipants 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 | Drug: MK-6916, Drug: Rescue MedicationParticipants 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 | Drug: Hydrocodone/acetaminophen (HB/APAP), Drug: Rescue MedicationParticipants 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 | Drug: MK-6916 Placebo, Drug: Rescue MedicationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 bunionectomy under regional anesthesia using a Mayo block, popliteal sciatic block and monitored anesthesia care (MAC)
Key exclusion criteria (15 listed)
- Has any of the following conditions in the index joint:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-6916120 mg or 70 mg oral tablet given every 12 hours (q12h) for 48 hours. | Drug | Arm 1: MK-6916 120 milligrams (mg), Arm 2: MK-6916 70 mg |
| Hydrocodone/acetaminophen (HB/APAP)Hydrocodone 5 mg/acetaminophen 325 mg given as oral capsule every 6 hours (q6h) for 48 hours. | Drug | Arm 3: hydrocodone 5 mg /acetaminophen 325 mg (HB/APAP) |
| MK-6916 PlaceboPlacebo oral table given every 6 hours (q6h) for 48 hours | Drug | Arm 4: MK-6916 Placebo |
| Rescue MedicationParticipants 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. | Drug | Arm 1: MK-6916 120 milligrams (mg), Arm 2: MK-6916 70 mg, Arm 3: hydrocodone 5 mg /acetaminophen 325 mg (HB/APAP), Arm 4: MK-6916 Placebo |
Primary outcome
Sum of the Pain Intensity Difference 0 to 48 Hours (SPID48)
Time frame: Up to approximately 48 hours
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.
5 secondary outcomes
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 16 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 48 hours
Time to ≥2-Point Improvement on the Numeric Pain Rating Scale (NPRS) Brief Pain Inventory-Short Form (BPI-SF) "Pain Now" Single Item Questionnaire
Time frame: Baseline and up to approximately 48 hours
Total Amount of Opioid Rescue Medication Used (mg) from 0 to 48 Hours
Time frame: Up to approximately 48 hours
Percentage of Participants who used any Opioid Rescue Medications from 0 to 48 hours
Time frame: Up to approximately 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-6916, Hydrocodone/acetaminophen (HB/APAP) and Rescue Medication in people with Pain Management, run by Merck Sharp & Dohme LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@merck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of the Pain Intensity Difference 0 to 48 Hours (SPID48) (time frame: Up to approximately 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.