A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

Exclusion Criteria

• •Chronic low back pain
• •Ongoing or history of alcohol or drug abuse
• •Body Mass Index greater 39
• •Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors
• •Known history or symptoms suspicious for cancer
• •Significant renal or liver disease
• •Spinal surgery within 1 year of study entry.
• •Subjects who are pregnant or lactating.
• •Subjects with unstable medical disease.
• •Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.