Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 530
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.

Detailed description:

Arms:
arm 1: 60-120 mg, oral, every day, 12 weeks arm 2: oral, daily, 12 weeks

Interventions: intervention 1: duloxetine hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase). intervention 2: oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)

Protocol document: