CompletedPhase 3

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

United States410 participantsStarted 2023-12-29

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Previously dosed with this formulation of MR-107A-02.
✕. 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.

Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.

Timeframe: 48 hours after randomization

NCT IDNCT06215820

SponsorViatris Specialty LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-24

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Previously dosed with this formulation of MR-107A-02.
✕. 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.