MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
579
tablet
over-encapsulated tablet
over-encapsulated tablet and/or tablet
Investigator site 210
Sheffield, Alabama, United States
Investigator site 213
Phoenix, Arizona, United States
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) 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
Summed Pain Intensity Difference (SPID) for tramadol versus placebo.
SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for tramadol versus placebo.
Time frame: 7 days after randomization
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus tramadol
SPID based on a 0 to 10-point numeric rating scale with activity (NRS-A) for MR-107A-02 versus tramadol.
Time frame: 48 hours after randomization
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Unilateral open inguinal herniorrhaphy with mesh under general anesthesia
Investigator site 202
Anaheim, California, United States
Investigator site 222
Bakersfield, California, United States
Investigator site 208
Riverside, California, United States
Investigator site 211
Miami, Florida, United States
Investigator site 206
Tampa, Florida, United States
Investigator site 207
Atlanta, Georgia, United States
Investigator site 205
Wichita, Kansas, United States
Investigator site 212
Bellaire, Texas, United States
...and 8 more locations