A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

Summary

The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS). This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.

Timeline

Start

2011-03

Primary completion

2017-05-31

Completion

2017-11-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Duloxetine - Acute vs Placebo - Acute; p = 0.052; LS mean change difference -0.65 (95% CI -1.30 to 0.00); Repeated Measures NCT01237587 ↗

paper For the primary measure, BPI average pain severity, the mean change was not statistically different between duloxetine and placebo (- 1.62 vs. -0.97, respectively; p = .052). PMID 31138224 ↗

Publications

• Upadhyaya HP, Arnold LM, Alaka K, Qiao M, Williams D, Mehta R. Efficacy and safety of duloxetine versus placebo in adolescents with juvenile fibromyalgia: results from a randomized controlled trial. Pediatr Rheumatol Online J. 2019 May 28;17(1):27. doi: 10.1186/s12969-019-0325-6.

Drugs

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

Indications