MR-107A-02 for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called MR-107A-02, a potential new drug, to evaluate its effectiveness and safety in easing pain after hernia surgery. Participants will be divided into groups to receive either MR-107A-02, tramadol, or a placebo (a non-active substance). The goal is to determine which treatment best reduces post-surgery pain. Individuals requiring hernia surgery and experiencing moderate to severe pain afterward might be suitable for this trial. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking pain relief treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MR-107A-02 is generally well-tolerated for treating acute pain. In studies involving surgical patients, the number of unwanted side effects was similar to those who received a placebo, a non-active treatment. This suggests that MR-107A-02 does not cause more side effects than a placebo.
However, the available safety information remains somewhat limited. More research with diverse populations is needed to fully understand its safety profile. So far, MR-107A-02 appears to be as safe as other treatments.12345Why do researchers think this study treatment might be promising for postoperative pain?
MR-107A-02 is unique because it offers a potentially more effective and consistent option for managing postoperative pain. Unlike traditional pain relievers like opioids, which can have significant side effects and risk of dependency, MR-107A-02 is designed to be taken twice daily, providing a steady pain relief without the peaks and troughs often associated with other medications. Additionally, MR-107A-02 may have a different mechanism of action, which could offer pain relief with fewer side effects. Researchers are excited about this treatment because it could offer a safer, more reliable way to manage pain after surgery.
What evidence suggests that MR-107A-02 might be an effective treatment for postoperative pain?
Research has shown that MR-107A-02, which participants in this trial may receive, effectively reduces sudden pain. In studies, MR-107A-02 relieved pain more effectively than a placebo, a pill with no active medicine. Patients experienced faster relief, feeling better sooner. This treatment also decreased the need for opioids, strong painkillers with potential side effects. These findings suggest that MR-107A-02 might be a useful option for managing pain after surgery.13456
Who Is on the Research Team?
Susanne Vogt
Principal Investigator
Viatris Inc.
Are You a Good Fit for This Trial?
This trial is for individuals experiencing acute pain after undergoing herniorrhaphy, which is surgery for a hernia repair. Specific eligibility criteria are not provided, but typically participants must be adults who have just had this surgery and meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-patient Treatment
Participants receive MR-107A-02, placebo, or tramadol for acute postoperative pain management
Out-patient Treatment
Participants continue receiving MR-107A-02 or placebo for pain management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MR-107A-02
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viatris Specialty LLC
Lead Sponsor
Mylan Specialty, LP
Industry Sponsor