At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 184 enrolled
Drug / intervention
Duloxetine +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.
Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome
In Brief
A Phase 3 clinical trial evaluating Duloxetine and Placebo for Fibromyalgia. Completed, enrolled 184 participants across 33 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesArgentina, India, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2010
Enrollment StartMar 2011
Primary CompletionMay 2017
Study CompletionNov 2017
TodayJul 2026
First PostedNov 9, 2010
Enrollment StartMar 1, 2011
Primary CompletionMay 31, 2017
Study CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.6 years ago
Interventions
Duloxetinedrug
Administered orally
Placebodrug
Administered orally