← Back to Search

Other

MR-107A-02 for 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

Requirement for a primary unilateral bunionectomy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours after randomization

Awards & highlights

Study Summary

This trial is studying a medication called MR-107A-02 to see if it is effective and safe for treating acute pain after a bunionectomy (surgery to remove a bunion).

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects of MR-107A-02 aren't listed, common side effects for pain medications like Tramadol include nausea, dizziness, headache, drowsiness, vomiting, constipation, lack of energy, sweating and dry mouth.

Eligibility Criteria

Inclusion Criteria

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

Select...

I need surgery for a bunion on one foot.

Select...

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

Select...

I experience moderate to severe pain after my nerve block wears off.

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.

Other outcome measures

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

Summed Pain Intensity Difference (SPID) for tramadol versus placebo.

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mylan Specialty, LPLead Sponsor

3 Previous Clinical Trials

789 Total Patients Enrolled

2 Trials studying Pain

641 Patients Enrolled for Pain

Susanne VogtStudy DirectorViatris Inc.

2 Previous Clinical Trials

644 Total Patients Enrolled

2 Trials studying Pain

644 Patients Enrolled for Pain

Frequently Asked Questions

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

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking participants. The trial was initially posted on December 29th, 2023 and underwent its most recent update on January 10th, 2024. Across a total of 11 sites, the trial aims to recruit a cohort of 405 individuals."

Answered by AI

Has MR-107A-02 received the official seal of approval from the FDA?

"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

In how many distinct clinics is this experimental investigation currently being conducted?

"This clinical trial has 11 recruitment sites, including Investigator site 110 in Riverside, Investigator site 107 in Carrollton, and Investigator site 108 in Tampa. There are also other locations involved in patient recruitment."

Answered by AI

What is the current number of participants being admitted to this clinical study?

"To meet the required enrollment target for this clinical trial, a total of 405 eligible candidates who satisfy the specified inclusion criteria are needed. Patients have the opportunity to participate in this study from various locations, including Investigator site 110 located in Riverside, Texas and Investigator site 107 situated in Carrollton, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06215820.

All > Acute Pain > Paid Studies Pasadena