A Study of Duloxetine in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Duloxetine 60 mg; Placebo
Intervention description: Duloxetine 60 mg taken orally once every day for 15 weeks; Placebo taken orally once every day for 15 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 393.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the effectiveness and safety of duloxetine in
      participants with fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants fulfilling the following criteria in the American College of Rheumatology
             1990 Criteria for the Classification of Fibromyalgia

          -  Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) -
             average pain severity item (Question 3)

        Exclusion Criteria:

          -  Participants with serious cardiovascular, hepatic, renal, respiratory, or
             hematological disease, or clinically significant laboratory or electrocardiogram
             abnormality which indicate a serious medical problem or require significant
             intervention in the judgment of the investigators

          -  Participants with alanine aminotransferase/aspartate aminotransferase of not less than
             100 international units per liter (IU/L) or total bilirubin of not less than 1.6
             milligrams per deciliter (mg/dL)

          -  Participants with serum creatinine level of not less than 2.0 mg/dL, participant who
             has undergone kidney transplantation or hemodialysis

          -  Participants with pain difficult to discriminate from pain associated with
             fibromyalgia or disease which disturbs the assessment

          -  Participants with treatment-refractory fibromyalgia

          -  Participants with thyroidal dysfunction, excluding those assessed by the investigator
             that the disorder is controlled as appropriate by 3-month or longer drug therapy

          -  Participants with present or past history of rheumatoid arthritis, inflammatory
             arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency

          -  Participants with an axis I condition according to Diagnostic and Statistical Manual
             of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except
             for major depressive disorders

          -  Participants with a lifetime diagnosis of bipolar disorder or schizoaffective
             disorder; or any other disorder with psychotic symptoms - based on the clinical
             opinion of the investigator

          -  Participants with personality disorder or mental retardation

          -  Participants with uncontrolled angle closure glaucoma

          -  Participants with present or past history of uncontrolled seizures or convulsion
             disorders

          -  Participants with suicidal ideation within past 6 months, with suicidal attempt within
             past 1 year

          -  Participants answering "yes" to any of the questions about active suicidal
             ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide
             Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior
             section)

          -  Participants with past history of multiple episodes of drug allergy

          -  Female participants who are pregnant, lactating, or who want to get pregnant during
             the study period. Male participants who want his partner to get pregnant

          -  Females of child-bearing potential who can't agree to utilize medically. acceptable
             and reliable means of birth control during the study and for 1 month following the
             last dose of the study

          -  Participants with a history of alcohol or any psychoactive substance abuse or
             dependence (including alcohol, but excluding nicotine and caffeine) within the past 1
             year

          -  Participants who have a positive urine drug screen for any substance of abuse
             (phencyclidine, cocaine, antihypnotic agent, or cannabis)

          -  Participants previously treated with duloxetine