S1202: Duloxetine Hydrochloride for Muscle/Joint Pain in Early-Stage Breast Cancer Receiving Hormone Therapy
|ClinicalTrials.gov Identifier: NCT01598298|
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : December 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Musculoskeletal Complications Pain||Drug: duloxetine hydrochloride Other: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer|
|Study Start Date :||May 2013|
|Primary Completion Date :||April 2017|
|Study Completion Date :||November 2017|
Experimental: Arm I
Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91.
Drug: duloxetine hydrochloride
Other Name: NSC-744012
Placebo Comparator: Arm II
Patients receive placebo PO QD on days 1-7, BID on days 8-84, and then QD on days 85-91.
- Reduction in average joint pain according to BPI-SF assessed up to 12 weeks [ Time Frame: 12 weeks ]
- Reduction in worst joint pain according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ]
- Reduction in pain interference according to the BPI-SF worst pain score assessed up to 12 weeks [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598298
Show 714 Study Locations
|Principal Investigator:||N. Lynn Henry, MD, PhD||University of Michigan Cancer Center|
|Study Chair:||Anne F. Schott, MD||University of Michigan Cancer Center|