At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 407 enrolled
Drug / intervention
duloxetine hydrochloride +2 moredrug
Likely dose
Not stated in 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.
An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain
In Brief
A Phase 4 clinical trial evaluating duloxetine hydrochloride, pregabalin, and 1 other intervention for Diabetic Neuropathy, Painful. Completed, enrolled 407 participants across 9 sites in 2 countries.
Detailed Summary
To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy, Painful
CountriesGermany, United States
CollaboratorsBoehringer Ingelheim
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedOct 2006
Primary CompletionAug 2009
Study CompletionNov 2009
TodayJul 2026
First PostedOct 11, 2006
Enrollment StartSep 1, 2006
Primary CompletionAug 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.7 years ago
Interventions
duloxetine hydrochloridedrug
Duloxetine (DLX) once daily (QD), orally (PO)
pregabalindrug
Pregabalin (PGB) orally (PO)
gabapentindrug
Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)