The purpose of the study is to assess the effectiveness and safety of duloxetine in
participants with fibromyalgia.
Minimum age: 20 Years.
Maximum age: 74 Years.
Gender(s): Both.
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