Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Viatris Specialty LLC
With
Mylan Specialty, LP
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
