An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathy, Painful

Treatments: Drug: gabapentin; Drug: duloxetine hydrochloride; Drug: pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385671

10822

F1J-US-HMEZ (Other Identifier)

Details and patient eligibility

About

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You must have been diagnosed with Diabetic Neuropathic Pain
• Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
• Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
• Patient must agree not to change dose of gabapentin between Visits 1 and 2
• You must have stable glycemic control

Exclusion criteria

• Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
• Current diagnosis or history of hemangiosarcoma
• Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
• Patients with uncontrolled narrow-angle glaucoma
• Presence of a current seizure disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 3 patient groups

Pregabalin

Active Comparator group

Description:

Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \& Germany) or 150 mg BID (Canada), PO for 10 weeks.

Treatment:

Drug: pregabalin

Duloxetine

Experimental group

Description:

Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.

Treatment:

Drug: duloxetine hydrochloride

Gabapentin + Duloxetine

Experimental group

Description:

Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.

Treatment:

Drug: gabapentin

Drug: duloxetine hydrochloride