Acute Pain, Pain, Post Operative Pain
Conditions
Keywords
Pain
Brief summary
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
Interventions
DRUGMR-107A-02
tablet
DRUGTramadol
over-encapsulated tablet
DRUGPlacebo
over-encapsulated tablet and/or tablet
PROCEDUREBunionectomy
Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Sponsors
Mylan Specialty, LP
Viatris Specialty LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo. | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo. | 7 days after randomization | Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. |
| Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo. | 7 days after randomization | Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summed Pain Intensity Difference (SPID) for tramadol versus placebo. | 48 hours after randomization | SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for tramadol versus placebo. |
| Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol | 48 hours after randomization | SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus tramadol. |
Countries
United States
Outcome results
None listed