CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 299 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.

Search/NCT01598298
NCT01598298Phase 3Completed

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer

SWOG Cancer Research Network·interventional·Posted May 15, 2012·Updated Dec 16, 2022

In Brief

A Phase 3 clinical trial evaluating duloxetine hydrochloride and placebo for Breast Cancer and 2 related conditions. Completed, enrolled 299 participants across 714 sites.

Detailed Summary

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2012
Enrollment StartMay 15, 2013
Primary CompletionDec 1, 2016
Study CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.1 years ago

Interventions

duloxetine hydrochloridedrug

Given PO

placeboother

Given PO