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

Viatris

Status and phase: Completed; Phase 3

Conditions: Acute Pain; Pain; Post Operative Pain

Treatments: Drug: Placebo; Procedure: Bunionectomy; Drug: Tramadol; Drug: MR-107A-02

Study type: Interventional

Funder types: Industry

Identifiers

NCT06215820

MR-107A-02-TFZ-3001

Details and patient eligibility

About

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Requirement for a primary unilateral bunionectomy
2. Has an American Society of Anesthesiologists Physical Status of I, II, or III.
3. 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
4. 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
5. 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.

Key Exclusion Criteria:

1. Previously dosed with this formulation of MR-107A-02.
2. Subjects with a contralateral foot bunionectomy in the past 6 months.
3. 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.
4. Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.
5. Body mass index (BMI) >40 kg/m2 at screening.
6. Body weight of <43 kg at screening.
7. History of GI bleeding or peptic ulcer disease.
8. Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
9. A history of bleeding disorders that may affect coagulation.
10. Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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410 participants in 3 patient groups, including a placebo group

MR-107A-02

Experimental group

Description:

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) .

Treatment:

Drug: MR-107A-02

Procedure: Bunionectomy

Tramadol

Active Comparator group

Description:

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.

Treatment:

Procedure: Bunionectomy

Drug: Tramadol

Drug: Placebo

Placebo

Placebo Comparator group

Description:

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:

Procedure: Bunionectomy

Drug: Placebo