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MR-107A-02 for Acute Pain

Phase 3

Recruiting

Research Sponsored by Mylan Specialty, LP

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an American Society of Anesthesiologists Physical Status of I, II, or III.

Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following end of surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after randomization

Awards & highlights

Study Summary

This trial is being conducted to see if MR-107A-02 is effective and safe in treating acute pain after herniorrhaphy (surgery to repair a hernia).

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects are not listed here, generally medications like MR-107A-02 could cause nausea, dizziness, or sleepiness. Tramadol may also lead to similar side effects including constipation or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

I experienced moderate to severe pain after surgery.

Select...

I need a one-sided groin hernia repair with mesh under full anesthesia.

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I have experienced pain of level 4 or higher after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.

Secondary outcome measures

Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.

Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol

+1 more

Side effects data

From 2022 Phase 2 trial • 111 Patients • NCT05317312

Blood bilirubin increased

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

MR-107A-02 1.25 mg Twice in a 24 Hour Period

MR-107A-02 5 mg Twice in a 24 Hour Period

MR-107A-02 15 mg Twice in a 24 Hour Period

Placebo Twice in a 24 Hour Period

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MR-107A-02

2022

Completed Phase 2

~120

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mylan Specialty, LPLead Sponsor

3 Previous Clinical Trials

664 Total Patients Enrolled

2 Trials studying Acute Pain

516 Patients Enrolled for Acute Pain

Susanne VogtStudy DirectorViatris Inc.

2 Previous Clinical Trials

519 Total Patients Enrolled

2 Trials studying Acute Pain

519 Patients Enrolled for Acute Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals undergoing treatment in this medical study?

"To fulfill the requirements of this clinical trial, a total of 530 eligible patients are sought. Participants have the opportunity to enroll in multiple locations including Investigator site 205 located in Wichita, Kansas and Investigator site 209 situated in Naperville, Illinois."

Answered by AI

What are the potential risks and hazards associated with MR-107A-02 for individuals?

"Based on the information provided, our team at Power rates the safety of MR-107A-02 as a 3. This is due to it being a Phase 3 trial, indicating that there is existing efficacy data and multiple rounds of safety data available."

Answered by AI

At how many different venues is this research study being conducted?

"Currently, this trial is actively recruiting patients from a total of 10 sites. These sites are spread across several cities including Wichita, Naperville, Anaheim, and other locations. To minimize travel demands for enrolled participants, it is advised to select the clinic that is closest to you."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is currently in the process of actively recruiting eligible patients. The initial posting date for the trial was December 29th, 2023, and it underwent its most recent update on January 10th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy

2023. "Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215859.

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