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579 Participants Needed

MR-107A-02 for Postoperative Pain

Recruiting at 18 trial locations

Overseen ByDiane Musselwhite

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viatris Specialty LLC

Must not be taking: Aspirin, NSAIDs

Disqualifiers: Obesity, Low weight, GI bleeding, others

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

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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 hernia surgery.

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.

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 pain mechanisms, such as neuropathic and inflammatory pain, which are often difficult to address with standard treatments. While traditional options like morphine focus on general pain relief, MR-107A-02 might work by reducing the hyperalgesic (increased sensitivity to pain) component, similar to NMDA antagonists, which could make it more effective in preventing chronic postsurgical pain.¹ ² ³ ⁴ ⁵

What data supports the effectiveness of the treatment MR-107A-02 for postoperative pain?

The research highlights the importance of multicomponent interventions in improving pain management after surgery, suggesting that treatments like MR-107A-02, which may involve multiple components, could be effective in managing postoperative pain.⁶ ⁷ ⁸ ⁹ ¹⁰

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

Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.

My health is good enough for surgery according to the ASA scale.

I experienced moderate to severe pain after surgery.

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Exclusion Criteria

Body mass index (BMI) >40 kg/m2 at screening.

I have been treated with MR 107A 02 before.

I have had surgery for an inguinal hernia in the last 2 years.

See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

In-patient Treatment

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

48 hours

In-patient stay

Out-patient Treatment

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

5 days

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

What Are the Treatments Tested in This Trial?

Interventions

MR-107A-02

Trial Overview The study is testing the effectiveness and safety of a medication called MR-107A-02 in managing post-surgery pain. It's being compared to Tramadol, a known pain reliever, and a placebo (a substance with no active drug).

How Is the Trial Designed?

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MR-107A-02Experimental Treatment1 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: TramadolActive Control2 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: PlaceboPlacebo Group1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Viatris Specialty LLC

Lead Sponsor

Trials

Recruited

170+

Mylan Specialty, LP

Industry Sponsor

Trials

Recruited

1,200+

Published Research Related to This Trial

A multicomponent intervention that included a clinical pain pathway and education for nurses significantly improved pain management in postoperative patients, particularly those with opioid tolerance, leading to faster pain relief and higher patient satisfaction.

Post-intervention, the time to achieve adequate pain relief for opioid-tolerant patients decreased from 32.7% requiring over 60 minutes to just 21.3%, and the average PACU discharge time improved by 53 minutes, indicating enhanced recovery quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Improve Postoperative Pain with a Clinical Pathway and Nursing Education Program.Naqib, D., Purvin, M., Prasad, R., et al.[2019]

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]