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

Eli Lilly and Company2 sites in 1 country339 target enrollmentNovember 2007

ConditionsDiabetic Neuropathies

InterventionsDuloxetine hydrochloride - 60 mg Duloxetine hydrochloride - 40 mg placebo

DrugsDuloxetine hydrochloride - 40 mg placebo Duloxetine hydrochloride - 60 mg

Overview

Phase: Phase 3
Intervention: Duloxetine hydrochloride - 60 mg
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Enrollment: 339
Locations: 2
Primary Endpoint: Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.
•Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit
•Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit
•Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2

Exclusion Criteria

•Participants who have undergone renal transplant or who are currently on renal dialysis.
•Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.
•Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg
•Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit
•Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.

Arms & Interventions

Duloxetine 60

duloxetine 60 milligram (mg) taken orally every day

Intervention: Duloxetine hydrochloride - 60 mg

Duloxetine 40

Duloxetine 40 mg taken orally every day

Intervention: Duloxetine hydrochloride - 40 mg

Placebo

placebo comparator taken orally every day

Intervention: placebo

Outcomes

Primary Outcomes

Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)

Time Frame: Baseline, 12 weeks

Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Secondary Outcomes

Patient Global Impression of Improvement Scale at Week 12(Week 12)
Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries(Baseline, 12 weeks)
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, 12 weeks)
Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries(Baseline, Week 12)
Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)(Week 12)
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
Change From Baseline in Brief Pain Inventory Severity Scores at Week 12(Baseline, Week 12)
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
Change From Baseline in Brief Pain Inventory Interference Scores at Week 12(Baseline, Week 12)
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12(Baseline, Week 12)