Trial Information

Summary: Do you have painful diabetic neuropathy (pain in your lower legs or feet)?

If you are a diabetic and have been experiencing neuropathic pain (pain in your lower legs or feet) due to diabetes for the past 6 months, you may qualify to participate in a study of an investigational drug. The primary purpose of this research study is to compare the effectiveness and safety of an investigational drug compared with duloxetine (an approved medication for the treatment of diabetic neuropathy) and placebo (a pill that does not contain any drug) in reducing pain in patients with painful diabetic neuropathy.

Participants receive an investigational drug, duloxetine or placebo (a pill that does not contain any drug) for 8 weeks and take study medication twice a day. A total of 8 office visits will be scheduled during which participants undergo evaluations including physical exam, neurological testing, laboratory tests, and electrocardiograms. Total study participation will last up to 12 weeks, including screening procedures, 8 weeks of treatment, and follow-up.

You may qualify for the study if you:

• Are between 18 – 70 years old.
• Have Type 1 or 2 diabetes.
• Have pain in your lower legs or feet due to painful diabetic neuropathy that has lasted for at least 6 months.
• Are in generally stable health.

If eligible, you will receive study-related procedures at no cost. Compensation for travel is also provided.

All information provided to us will be kept confidential.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.