NCT01552057.

Trial name or title	A phase III clinical trial of duloxetine in participants with fibromyalgia
Methods	Randomised, double‐blind (subject, investigator), placebo‐controlled, parallel assignment, safety/efficacy study
Participants	Participants with fibromyalgia aged 20 to 74 years Inclusion criteria: fulfilling American College of Rheumatology 1990 criteria for fibromyalgia pain severity ≥ 4 by Brief Pain Inventory (BPI) ‐ average pain severity item (question 3)
Interventions	Duloxetine hydrochloride orally 60 mg for 15 weeks or oral placebo for 15 weeks
Outcomes	Changes measured from baseline to 14 week endpoint Primary: 24‐Hour Average Pain Severity Item of the BPI‐Modified Short Form Score Secondary: Patient Global Impression ‐ improvement (PGI‐I) at endpoint Clinical Global Impression of improvement (CGI‐I) at endpoint Fibromyalgia Impact Questionnaire (FIQ) 36‐Item Short‐Form Health Survey (SF‐36) Beck Depression Inventory‐II (BDI) Widespread Pain Index and Symptom Severity in American College of Rheumatology Fibromyalgia Diagnostic Criteria 2010 Average Pain and Worst Pain Severity Score within 24‐hours in Patient Diary BPI Pain Severity Items and Interference Items of the BPI‐Modified Short Form Score
Starting date	March 2012
Contact information	Eli Lilly and Company, Shionogi. Tel: 1‐877‐CTLILLY (1‐877‐285‐4559) or 1‐317‐615‐4559
Notes	NCT01552057