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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
Awards & highlights

Study Summary

MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.

Eligible Conditions
  • Pain
  • Postoperative Pain
  • Acute 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Summed Pain Intensity Difference (SPID)
Secondary outcome measures
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
2022
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Mylan Specialty, LPLead Sponsor
3 Previous Clinical Trials
1,083 Total Patients Enrolled
2 Trials studying Pain
935 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.
Recent research and studies
clinicaltrials.govStudy
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
2022. "Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05317312.
~37 spots leftby Apr 2025
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