A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

Lilly

Status and phase

Completed

Phase 4

Conditions

Fibromyalgia

Treatments

Drug: placebo

Drug: duloxetine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00673452

12220

F1J-US-HMGB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

530 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female patients
aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
all females must test negative for pregnancy at the time of enrollment
have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion criteria

have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
have regional pain syndrome, multiple surgeries or failed back syndrome
have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)