Conditions: Diabetic Neuropathy, Painful
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 811
Healthy volunteers: no

Brief summary:
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Detailed description:

Arms:
arm 1: Initial Treatment:

Duloxetine 30 milligram (mg) daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week

Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks arm 2: Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 300 mg (150 mg twice daily) daily for 8 weeks

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks arm 3: Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week

Pregabalin 600 mg (300 mg twice daily) daily for 7 weeks arm 4: Initial Treatment:

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 60 mg daily for 8 weeks

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Interventions: intervention 1: Duloxetine intervention 2: Pregabalin intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Protocol document: