A Study for the Treatment of Diabetic Peripheral Neuropathic Pain

Phase 3CompletedNCT00552175

Eli Lilly and Company339 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

339

Conditions

Diabetic Neuropathies

Interventions

Duloxetine hydrochloride - 40 mgDRUG

duloxetine 40 mg taken orally every day

placeboDRUG

placebo taken orally every day

Duloxetine hydrochloride - 60 mgDRUG

duloxetine 60 mg taken orally every day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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 1. * 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 1. * 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 1. * Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.

Locations (25)

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)

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).

Time frame: Baseline, 12 weeks

Secondary Outcomes

Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries

Time frame: 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)

Pain severity for worst pain and night pain as measured by an 11-point numerical rating scale, collected by diaries and expressed as weekly means. A self-reported scale that measures the severity of pain based on the worst pain and night pain experienced over the past 24-hours. The worst pain and night pain severity scores each range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame: Baseline, 12 weeks

Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Aichi, Japan

Aomori, Japan

Chiba, Japan

Fukui, Japan

Fukuoka, Japan

Fukushima, Japan

Gunma, Japan

Hiroshima, Japan

Hokkaido, Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT -5 hours, ETS), or speak with your personal physician

Hyōgo, Japan

...and 15 more locations

Time frame: Baseline, Week 12

Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time frame: Week 12

Patient Global Impression of Improvement Scale at Week 12

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time frame: Week 12

Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)

A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Each question has a total range of scores from 0 to 10.

Time frame: Baseline, Week 12

Change From Baseline in Brief Pain Inventory Severity Scores at Week 12

Time frame: Baseline, Week 12

Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)

The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each question has a total range of scores from 0 to 10.

Time frame: Baseline, Week 12

Change From Baseline in Brief Pain Inventory Interference Scores at Week 12

Time frame: 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)

A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score ranges from 0 (no depression) to 63 (severe depression).

Time frame: Baseline, Week 12

Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12

Time frame: Baseline, Week 12