Conditions: Diabetic Neuropathy, Painful
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 314
Healthy volunteers: no

Brief summary:
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: placebo intervention 2: pregabalin intervention 3: pregabalin
Intervention descriptions: intervention 1: Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 2: Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose) intervention 3: Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Protocol document: