Summary:
A multi-center, randomized, double-blind, placebo-controlled study with an open-label run-in to assess the efficacy and safety of once-daily study medication in subjects with moderate to severe chronic low back pain.
Qualified Participants Must:
Be at least 18 years of age
Back pain related to nonmalignant and nonneuropathic conditions and must not radiate below the knee
Be on a stable dose of analgesic medicationfor at least 14 days prior to screening
Be willing to use an electronic diary on a daily basis
be willing to complete audiologic (hearing) assessments
Qualified Participants May Receive:
All study-related exams, lab work, and medications are provided free of charge and compensation is available for time and travel.