A Study for the Treatment of Painful Diabetic Neuropathy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 31, 2007

Last Updated Date

December 21, 2007

Start Date ^†

November 2007

Current Primary Outcome Measures ^†

Reduction in average pain severity as measured by an 11-point Likert scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00552175 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Pain severity for worst pain and night pain as measured by an 11-point Likert scale. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Brief Pain Inventory to measure the severity of pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Beck Depression Inventory-II (BDI-II) total score. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Safety [ Time Frame: 3.5 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study for the Treatment of Painful Diabetic Neuropathy

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Diabetic Neuropathies

Intervention ^†

Drug: Duloxetine hydrochloride
Drug: placebo

Study Arms / Comparison Groups

Experimental: Duloxetine 60 mg QD
Placebo Comparator: PO
Experimental: Duloxetine 40 mg QD

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

300

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Male or female outpatients aged 20 years or older but less than 80 years at the time of consent.
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.
Patients with HbA1c less than or equal to 9.0 percent at Visit 1.
Patients 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
Patients 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:

Patients who have undergone renal transplant or who are currently on renal dialysis.
Patients 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.
Patients with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg)
Patients with ALT or AST greater than or equal to 100 U/L at Visit 1.
Patients with use of any of the prohibited concomitant drugs or prohibited concomitant therapies after Visit 1.

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559

1-317-615-4559

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00552175

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

0715N0831, F1J-JE-HMFX

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Shionogi

Investigators ^†

Study Director:

Call 1-877-CTLILLY(1-877-285-4559) OR 1-317-615-4559 Mon-Fri 9 AM-5 PM Eastern time (UTC/GMT-5 hours,EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.