Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

Exclusion criteria

• . Has muscular pain secondary to acute trauma or fractures (e.g., due to osteoporosis). Such conditions could have been ruled out based on medical history, x-ray, or physical examination.
• . Has received any investigational compound within 30 days prior to Screening.
• . If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
• . Has a history of drug abuse or recent (within the last 12 months) history of excessive alcohol consumption defined as \>2 drinks/day (\>90 ml of 80 proof alcohol or equivalent).
• . Has mild, moderate, severe liver impairment.
• . Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• . Takes any concomitant medication including over-the-counter and herbal products for muscle spasms. If a participant is taking such medications, the medications has to be discontinued before starting the study.
• . Takes or took within last 14 days medications, such as: