Trial Information

Summary: A Randomized-Withdrawal Phase III Study Evaluating the Safety and Efficacy of CG5503 Extended-Release (ER) in Subjects with Painful Diabetic Peripheral Neuropathy (DPN)

The primary objective of the trial is to demonstrate the efficacy of CG5503 ER versus placebo and to assess safety and tolerability of CG5503 ER orally administered at doses of 100 mg to 250 mg (base) twice daily (BID) in subjects with moderate to severe pain due to chronic DPN who demonstrated an initial treatment effect after a 3-week open-label titration period.

The maximum duration of the active treatment will be 15 weeks for each individual trial subject (including a 3-week open-label titration period and 12-week double-blind maintenance period).

Approximately 760 male and female subjects of at least 18 years of age with pain due to chronic DPN requiring analgesic treatment will be included in this trial.

Inclusion

• Male or female subjects aged 18 years or older.
• Subjects with Type 1 or Type 2 diabetes mellitus must have a documented clinical diagnosis of painful DPN with symptoms and signs for at least 6 months, and pain present at the time of screening.
• The Investigator considers the subject’s blood glucose to be controlled by a diet, oral hypoglycemics, or insulin for at least 3 months prior to enrolling in the study. This control should be documented by figures of glycated hemoglobin (HbA1c) no greater than 11% at screening.

Exclusion

• Concurrent participation in another trial, or within 30 days of enrollment into this trial.
• Previous participation in this or other trials with CG5503.
• History of alcohol and/or drug abuse in the Investigator’s judgment, based on subject history and physical examination.

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.