Clinical trial NCT06215820: Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Post Operative Pain
Pain
Keywords: Pain
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mylan Specialty, LP
First posted: 2024-01-22
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
timeFrame: 48 hours after randomization
Secondary outcomes:
measure: Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
timeFrame: 7 days after randomization
measure: Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
timeFrame: 7 days after randomization
Other outcomes:
measure: Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
timeFrame: 48 hours after randomization
measure: Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
timeFrame: 48 hours after randomization
Locations:
city: Sheffield
country: United States
facility: Investigator site 114
state: Alabama
city: Phoenix
country: United States
facility: Investigator site 115
state: Arizona
city: Anaheim
country: United States
facility: Investigator site 103
state: California
city: Riverside
country: United States
facility: Investigator site 110
state: California
city: Miami
country: United States
facility: Investigator site 112
state: Florida
city: Tampa
country: United States
facility: Investigator site 108
state: Florida
city: Atlanta
country: United States
facility: Investigator site 109
state: Georgia
city: O'Fallon
country: United States
facility: Investigator site 104
state: Illinois
city: Pasadena
country: United States
facility: Investigator site 102
state: Maryland
city: Bellaire
country: United States
facility: Investigator site 113
state: Texas
city: Carrollton
country: United States
facility: Investigator site 107
state: Texas
city: Houston
country: United States
facility: Investigator site 106
state: Texas
city: McAllen
country: United States
facility: Investigator site 111
state: Texas
city: San Antonio
country: United States
facility: Investigator site 105
state: Texas
city: Salt Lake City
country: United States
facility: Investigator site 101
state: Utah
Study officials:
affiliation: Viatris Inc.
name: Susanne Vogt
role: STUDY_DIRECTOR
References: