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

Tracking Information

First Received Date ^ICMJE

March 19, 2008

Last Updated Date

November 18, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Brief Pain Inventory to measure the severity of pain. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Beck Depression Inventory-II (BDI-II) total score. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Neuropathies

Intervention ^ICMJE

Drug: Duloxetine hydrochloride

Study Arms / Comparison Groups

Experimental: Duloxetine 40 mg QD, PO, 1 year
Experimental: Duloxetine 60 mg QD, PO, 1 year

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Outpatients who have completed the 13-week treatment in the preceding study (Protocol No.0715N0831).
Patients who desire to receive continued treatment with LY248686 from the preceding study.
Patients with latest 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.

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

1-317-615-4559

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00641719

Responsible Party

Chief Medical Officer, Eli Lilly

Study ID Numbers ^ICMJE

12194, F1J-JE-HMFY

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Shionogi

Investigators ^ICMJE

Study Director:

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

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP