A Multi-Center, Randomized, Double-Blind, Placebo- (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Overview
- Phase
- Phase 3
- Intervention
- MR-107A-02
- Conditions
- Acute Pain
- Sponsor
- Viatris Specialty LLC
- Enrollment
- 408
- Locations
- 15
- Primary Endpoint
- Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Requirement for a primary unilateral bunionectomy
- •Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- •Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block
- •Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block
- •Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.
Exclusion Criteria
- •Previously dosed with this formulation of MR-107A-
- •Subjects with a contralateral foot bunionectomy in the past 6 months.
- •Subject has a concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the bunionectomy, and which may confound the postoperative assessments.
- •Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.
- •Body mass index (BMI) \>40 kg/m2 at screening.
- •Body weight of \<43 kg at screening.
- •History of GI bleeding or peptic ulcer disease.
- •Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
- •A history of bleeding disorders that may affect coagulation.
- •Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.
Arms & Interventions
MR-107A-02
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) .
Intervention: MR-107A-02
MR-107A-02
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) .
Intervention: Bunionectomy
Tramadol
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.
Intervention: Tramadol
Tramadol
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.
Intervention: Placebo
Tramadol
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.
Intervention: Bunionectomy
Placebo
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.
Intervention: Placebo
Placebo
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.
Intervention: Bunionectomy
Outcomes
Primary Outcomes
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
Time Frame: 48 hours after randomization
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
Secondary Outcomes
- Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.(7 days after randomization)
- Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.(7 days after randomization)