Expired Study
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Clinical Trial 2446

New York, NY 10022

Study Summary:

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.

Study Summary:
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.

Qualified Participants Must:

• Be 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
• Be generally in stable health

Qualified Participants May Receive:

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

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.