CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
Duloxetine +1 moredrug
Likely dose
Duloxetine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01179672
NCT01179672Phase 3Completed
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Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo

Eli Lilly and Company·interventional·Posted Aug 11, 2010·Updated Oct 13, 2014

In Brief

A Phase 3 clinical trial evaluating Duloxetine and Placebo for Diabetic Neuropathy, Painful. Completed, enrolled 405 participants across 15 sites.

Detailed Summary

The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2010
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.9 years ago

Interventions

Duloxetinedrug

30 mg administered orally (po), QD for 1 week; 60 mg administered po, QD for remaining 11 weeks; 30 mg administered po, QD for 1 week during taper period

Placebodrug

Administered po, QD for 12 weeks; administered po, QD for 1 week during taper period