MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
410
tablet
over-encapsulated tablet
over-encapsulated tablet and/or tablet
Investigator site 114
Sheffield, Alabama, United States
Investigator site 115
Phoenix, Arizona, United States
Investigator site 103
Anaheim, California, United States
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
Time frame: 48 hours after randomization
Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.
Number of doses of opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
Time frame: 7 days after randomization
Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.
Proportion of subjects using no opioid rescue medication over the combined in-patient and outpatient treatment phases MR-107A-02 versus placebo.
Time frame: 7 days after randomization
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Primary unilateral bunionectomy with first metatarsal osteotomy under regional anesthesia
Investigator site 110
Riverside, California, United States
Investigator site 112
Miami, Florida, United States
Investigator site 108
Tampa, Florida, United States
Investigator site 109
Atlanta, Georgia, United States
Investigator site 104
O'Fallon, Illinois, United States
Investigator site 102
Pasadena, Maryland, United States
Investigator site 113
Bellaire, Texas, United States
...and 5 more locations