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MR-107A-02 15 mg twice in a 24 hour period for Pain

Phase 2
Waitlist Available
Research Sponsored by Mylan Specialty, LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours

Summary

This trial is testing a new treatment called MR-107A-02 to see if it helps patients recover better after dental surgery.

Eligible Conditions
  • Pain
  • Acute Pain
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Summed Pain Intensity Difference (SPID)
Secondary study objectives
Pain Intensity Using a Number Pain Rating Scale Utilizing 6-hour Windowed Last Observation Carried Forward (W6LOCF)
Patient's Global Assessment of Pain Control
Rescue Medication Use
+2 more

Side effects data

From 2022 Phase 2 trial • 111 Patients • NCT05317312
7%
Blood bilirubin increased
4%
Nausea
100%
80%
60%
40%
20%
0%
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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MR-107A-02 5 mg twice in a 24 hour periodExperimental Treatment1 Intervention
Oral tablet, one day of dosing
Group II: MR-107A-02 15 mg twice in a 24 hour periodExperimental Treatment1 Intervention
Oral tablet, one day of dosing
Group III: MR-107A-02 1.25 mg twice in a 24 hour periodExperimental Treatment1 Intervention
Oral tablet, one day of dosing
Group IV: Placebo twice in a 24 hour periodPlacebo Group1 Intervention
Oral tablet, one day of dosing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MR-107A-02
2023
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Mylan Specialty, LPLead Sponsor
3 Previous Clinical Trials
1,128 Total Patients Enrolled
2 Trials studying Pain
980 Patients Enrolled for Pain
~31 spots leftby Nov 2025
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