A Phase 3 interventional study of MR-107A-02 and Tramadol in Acute Pain, Post Operative Pain and Pain, sponsored by Viatris Specialty LLC. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Viatris Specialty LLC · Phase 3, Interventional, and Treatment
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 410 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Viatris Specialty LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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) .
Drug: MR-107A-02 · Procedure: Bunionectomy
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.
Drug: Tramadol · Drug: Placebo · Procedure: Bunionectomy
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.
Drug: Placebo · Procedure: Bunionectomy
tablet
over-encapsulated tablet
over-encapsulated tablet and/or tablet
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
Time frame: 48 hours after randomization
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
Time frame: 7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
Time frame: 7 days after randomization
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for tramadol versus placebo.
Time frame: 48 hours after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus tramadol.
Time frame: 48 hours after randomization
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Viatris Specialty LLC