a study of duloxetine in fibromyalgia

Conditions: Fibromyalgia

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