MR-107A-02 for Postoperative Pain

Recruiting at 14 trial locations

Overseen By Pushpa Baral

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Specialty LLC

Must not be taking: Aspirin, NSAIDs

Disqualifiers: BMI >40, GI bleeding, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

410 Participants Needed

Trial Summary

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.

How is the drug MR-107A-02 different from other drugs for postoperative pain?

MR-107A-02 may offer a unique approach to managing postoperative pain by potentially targeting specific mechanisms involved in chronic postsurgical pain, such as neuropathic and inflammatory pain pathways, which are not always addressed by standard treatments like morphine. This could make it particularly beneficial for patients at high risk of developing chronic pain after surgery. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new medication called MR-107A-02 to see if it can safely and effectively reduce pain in patients who have had bunion surgery.

Research Team

Susanne Vogt

Principal Investigator

Viatris Inc.

Eligibility Criteria

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

I experience pain level 4 or higher after a specific nerve block procedure.

I need surgery for a bunion on one foot.

My health is good enough for surgery, according to anesthesia guidelines.

Exclusion Criteria

I have a painful condition not related to my foot surgery that needs pain management.

My body weight is less than 43 kg.

I have an active inflammatory bowel condition like Crohn's or ulcerative colitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-patient Treatment

Participants receive MR-107A-02, tramadol, or placebo for acute postoperative pain management

48 hours

In-patient stay

Out-patient Treatment

Participants continue receiving MR-107A-02 or placebo for pain management at home

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

Treatment Details

Interventions

• MR-107A-02
• Placebo
• Tramadol

Trial Overview The study is testing MR-107A-02's effectiveness and safety in managing post-surgical pain from a bunionectomy compared to Tramadol (a known pain medication) and a placebo (an inactive substance).

Participant Groups

Group I: MR-107A-02 Experimental Treatment 1 Intervention

15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .

Group II: Tramadol Active Control 2 Interventions

50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization). Placebo will be administered during out patient phase.

Group III: Placebo Placebo Group 1 Intervention

Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.

Who Is Running the Clinical Trial?

Viatris Specialty LLC

Lead Sponsor

Trials

3

Recruited

170+

Mylan Specialty, LP

Industry Sponsor

Trials

4

Recruited

1,200+

Findings from Research

Effective postoperative pain management requires a multimodal approach tailored to the specific type of surgery, which can enhance patient comfort and reduce complications.

Recent advancements in pain management include the rediscovery of existing medications like Gabapentin and new combinations like oral oxycodone with naloxone, highlighting the ongoing evolution of analgesic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New substances and applications for postoperative pain therapy]. Pogatzki-Zahn, EM., Zahn, PK.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Predictors of chronic pain following surgery. What do we know?]. [2022]

2. India pubmed.ncbi.nlm.nih.gov

The Effect of Gabapentin Plus Celecoxib on Pain and Associated Complications After Laminectomy. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Chronic pain after surgery]. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

[New substances and applications for postoperative pain therapy]. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of intravenous patient controlled ketamine analgesiaon postoperative pain in opium abusers. [2021]