drugset

drugset / Trial / NCT01552057

A Study of Duloxetine in Fibromyalgia

NCT01552057 ↗

Phase 3 Completed 393 enrolled Eli Lilly and Company Shionogi · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.

Timeline

Start: 2012-03
Primary completion: 2013-12
Completion: 2013-12

Outcome

Mixed primary results

registry Duloxetine 60 mg vs Placebo; p = 0.0988; Mean Difference (Final Values) -0.32 (95% CI -0.70 to 0.06) NCT01552057 ↗

registry Duloxetine 60 mg vs Placebo; p = 0.0113; Mean Difference (Final Values) -0.40 (95% CI -0.71 to -0.09) NCT01552057 ↗

paper Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo PMID 26296539 ↗

Publications

Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015 Aug 22;17(1):224. doi: 10.1186/s13075-015-0718-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duloxetine	Small molecule	60 mg	Oral

Indications