A Study of Duloxetine in Fibromyalgia

Lilly

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: Placebo

Drug: Duloxetine 60 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01552057

14377

F1J-JE-HMGZ (Other Identifier)

Details and patient eligibility

About

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

Enrollment

393 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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