A Long-term Study for the Treatment of Painful Diabetic Neuropathy

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetic Neuropathies

Treatments: Drug: Duloxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641719

F1J-JE-HMFY (Other Identifier)

12194

Details and patient eligibility

About

The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Enrollment: 258 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
• Patients who desire to receive continued treatment with LY248686 from the preceding study.
• Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
• Patients who can provide written consent in person.

Exclusion criteria

• Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
• Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
• Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 2 patient groups

Duloxetine 40 mg

Experimental group

Description:

Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year

Treatment:

Drug: Duloxetine hydrochloride

Drug: Duloxetine hydrochloride

Duloxetine 60 mg

Experimental group

Description:

Duloxetine 60 mg QD, PO, 1 year

Treatment:

Drug: Duloxetine hydrochloride

Drug: Duloxetine hydrochloride