The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
549
Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
Time frame: 16 weeks
Efficacy: daily (past 24 hours) worst pain intensity score (WPI)
Time frame: 16 Weeks
Safety: Incidence of TEAEs, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment
Time frame: 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site 207
Birmingham, Alabama, United States
Site 202
Mobile, Alabama, United States
Site 253
Phoenix, Arizona, United States
Site 260
Phoenix, Arizona, United States
Site 268
Phoenix, Arizona, United States
Site 282
Tucson, Arizona, United States
Site 217
Anaheim, California, United States
Site 280
Anaheim, California, United States
Site 220
La Mesa, California, United States
Site 235
Laguna Hills, California, United States
...and 64 more locations