Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Exclusion Criteria

• •Presence of pain conditions that cannot be distinguished from DPN
• •Presence of significant renal disease, as indicated by a serum creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL), or presence of significant hepatic disease
• •Have a history of a seizure disorder
• •Presence of serious or unstable cardiovascular disease, respiratory disease, hematologic illness, or a psychiatric condition
• •History of evidence of symptomatic orthostatic hypotension
• •History of a major depressive disorder, generalized anxiety disorder, eating disorder, or substance abuse (including alcohol) within the past year
• •History or evidence of mania, bipolar disorder, or psychosis
• •History of allergy to acetaminophen or duloxetine
• •Score of greater than or equal to 18 on the Beck Depression Inventory II (BDI-II) or score of greater than zero on Item 9 of the BDI-II
• •Use of any of the following concomitant medications: fluvoxamine; quinolone antimicrobials (ciprofloxacin and enoxacin); selective serotonin reuptake inhibitors (SSRIs); serotonin norepinephrine reuptake inhibitors (SNRIs); tricyclic antidepressants; opioids; nonsteroidal anti-inflammatory drugs (NSAIDS); anticonvulsants; aspirin (with the exception of low-dose aspirin as cardiovascular prophylaxis); or cytochrome P4503A (CYP3A) and P-glycoprotein transporter inhibitors
• •Pregnant, lactating, or plans to become pregnant during the study
• •Presence of foot or toe amputation
• •Participation in another study with an investigational compound within the previous 30 days prior to study medication administration, or concurrent participation in another clinical study