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

Eli Lilly and Company258 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Diabetic Neuropathies

Interventions

Duloxetine hydrochlorideDRUG

Duloxetine 40 mg QD, PO, 1 year

Duloxetine hydrochlorideDRUG

Duloxetine 60 mg QD, PO, 1 year

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (25)

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event (AE)

See the Reported Adverse Events section for details.

Time frame: baseline through 1 year

Secondary Outcomes

Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.

A scale that measures the participant'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: 1 year

Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale

A scale that measures the participant'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: baseline, 1 year

Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint

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.

Time frame: 1 year

Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores

Time frame: baseline, 1 year

Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint

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

Hyōgo, Japan

...and 15 more locations

Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).

Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores

Time frame: baseline, 1 year

Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint

A 21-item, participant-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 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Time frame: 1 year

Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score

Time frame: baseline, 1 year