MR-107A-02 for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine how well the new drug MR-107A-02 relieves pain after bunion surgery. Researchers will compare MR-107A-02 to tramadol, a common pain medication, and a placebo to assess which is most effective and safe. Individuals who have undergone bunion surgery and experience moderate to severe pain afterward might be suitable for this trial. Participants should be able to understand and complete study requirements, such as filling out diaries and questionnaires. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potential new pain relief option.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have a condition that requires pain medication not related to the bunionectomy, you may be excluded from the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that MR-107A-02 is generally safe and well-tolerated. In earlier studies, the treatment caused about the same number of side effects as a placebo, which is a harmless pill like a sugar pill. This finding suggests that MR-107A-02 is relatively safe, as participants did not experience more side effects than those taking the placebo. This is a positive sign for its safety.12345
Why do researchers think this study treatment might be promising for postoperative pain?
Researchers are excited about MR-107A-02 because it offers a potentially new way to manage postoperative pain. Unlike standard treatments like opioids or NSAIDs, MR-107A-02 is administered as a 15 mg dose twice daily, which could simplify dosing schedules and improve patient compliance. Additionally, MR-107A-02 might provide effective pain relief with fewer side effects compared to traditional options like tramadol, which is often taken every six hours and can have more pronounced side effects. This innovative approach could make postoperative recovery more comfortable and manageable for patients.
What evidence suggests that MR-107A-02 could be an effective treatment for postoperative pain?
Research has shown that MR-107A-02, which participants in this trial may receive, effectively eases pain after bunion surgery. It provides better pain relief than a placebo, helping patients recover more quickly. Patients using MR-107A-02 required fewer opioids, which are strong painkillers with potential side effects. One study found that people experienced faster and more noticeable pain reduction with MR-107A-02. This suggests that MR-107A-02 could be a promising option for managing post-surgery pain effectively and safely.14567
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 bunionectomy surgery. Specific eligibility criteria are not provided, but typically participants must be adults who have undergone the procedure 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, tramadol, or placebo for acute postoperative pain management
Out-patient Treatment
Participants continue receiving MR-107A-02 or placebo for pain management at home
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MR-107A-02
- Placebo
- Tramadol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viatris Specialty LLC
Lead Sponsor
Mylan Specialty, LP
Industry Sponsor