Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

Exclusion Criteria

• •Subject has received prior treatment with pregabalin for PDPN and was considered unresponsive or intolerant.
• •Subject has tried and failed 3 or more drugs to treat PDPN within the past 3 years. Drugs must have been administered at therapeutic doses and have been administered for an adequate period of time.
• •Subject has a known hypersensitivity to ASP3662, pregabalin, gabapentin or acetaminophen, or their formulation components.
• •Subject has significant pain (moderate or above) due to causes other than PDPN.
• •Subject has a history of painful peripheral neuropathy due to a cause other than diabetes.
• •Subject has any lower extremity amputation
• •Subject has a current or previous foot ulcer within the past 3 months as described by medical history and/or medical examination.
• •Subject has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years.
• •Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine at Screening.
• •Subject has creatinine clearance \< 60 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation) at Screening.
• •Subject tests positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody at Screening or has a known history of a positive test for human immunodeficiency virus (HIV) infection.
• •Subject has a positive drug screen for alcohol or drugs of abuse at Screening and/or Randomization. Subjects who are on low doses of benzodiazepines for sleep with a legitimate prescription will be allowed into the study. In addition, subjects with a positive drug screen at Randomization will be excluded.
• •Subject is currently using protocol specified non-permitted medications including OTC products and is unable or does not choose to discontinue them.
• •Subject has planned an elective surgery during planned study participation.