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

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

This study is currently recruiting participants.

Study NCT00641719. Last updated on November 18, 2008. Information provided by Eli Lilly and Company

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

Descriptive Information Fields

Brief Title ^†

A Long-Term 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 - 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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Diabetic Neuropathies

Intervention ^†

Drug: Duloxetine hydrochloride

MEDLINE PMIDs

Links

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

300

Start Date ^†

March 2008

Completion Date

February 2010

Eligibility Criteria ^†

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 ^††

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

1-317-615-4559

Location Countries ^†

Japan

Administrative Information Fields

NCT ID ^†

NCT00641719

Organization ID

12194

Secondary IDs ^††

F1J-JE-HMFY

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 - 5PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2008

First Received Date ^†

March 19, 2008

Last Updated Date

November 18, 2008

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