Enrollment Criteria
Current acute back pain and/or stiffness due to acute and painful muscle spasms
Numerical Rating Scale (NRS) pain of 4 or more at baseline
Study initiated December 2020; topline data expected Q4 2021
SUBJECTS:
#: 1000
Age: 18 to 64 years
OMZYA® 50 mg TID (150 mg/day)
OMZYA® 200 mg TID (600 mg/day)
OMZYA® 100 mg TID (300 mg/day)
Subject-Rated Pain Numerical Rating Scale (NRS) on Day 1, 4, 14
Daily electronic patient-reported (ePRO) Assessments and Dosing Diary
Primary Endpoint:
Subject-rated Pain
(NRS) on Day 14
0 = No Pain,
10 = Worst Possible Pain
Secondary Endpoint:
Measures of sleepiness
(ESS; VAS)
Follow-up
