A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase

Eli Lilly and Company1 site in 1 country258 target enrollmentMarch 2008

Overview

Phase: Phase 3
Intervention: Duloxetine hydrochloride
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Enrollment: 258
Locations: 1
Primary Endpoint: Number of Participants Who Experienced an Adverse Event (AE)
Status: Completed
Last Updated: 15 years ago

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

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

March 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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
•Patients who can provide written consent in person.

•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.

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

Intervention: Duloxetine hydrochloride

Duloxetine 60 mg QD, PO, 1 year

Intervention: Duloxetine hydrochloride

Number of Participants Who Experienced an Adverse Event (AE)

Time Frame: baseline through 1 year

See the Reported Adverse Events section for details.

Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.(1 year)
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint(1 year)
Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint(1 year)
Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score(baseline, 1 year)
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint(1 year)
Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale(baseline, 1 year)
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores(baseline, 1 year)
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores(baseline, 1 year)