At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 231 enrolled
Drug / intervention
duloxetine hydrochloride +1 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.
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
In Brief
A Phase 3 clinical trial evaluating duloxetine hydrochloride and placebo for Neurotoxicity and 3 related conditions. Completed, enrolled 231 participants across 475 sites.
Detailed Summary
RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartApr 2008
Primary CompletionJan 2012
Study CompletionMar 2013
TodayJul 2026
First PostedJun 21, 2007
Enrollment StartApr 1, 2008
Primary CompletionJan 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.0 years ago
Interventions
duloxetine hydrochloridedrug
Given orally
placeboother
Given orally