A Study of Duloxetine in Fibromyalgia

NCT ID: NCT01552057

Last Updated: 2015-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 393 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Duloxetine 60 mg

Duloxetine hydrochloride up to 60 milligrams (mg) orally for 15 weeks

Group Type: EXPERIMENTAL

Duloxetine 60 mg

Intervention Type: DRUG

Duloxetine 60 mg taken orally once every day for 15 weeks

Placebo

Placebo orally for 15 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo taken orally once every day for 15 weeks

Interventions

Duloxetine 60 mg

Duloxetine 60 mg taken orally once every day for 15 weeks

Intervention Type: DRUG

Placebo

Placebo taken orally once every day for 15 weeks

Intervention Type: DRUG

Other Intervention Names

LY248686; Cymbalta

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shionogi

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miyagi, , Japan

Countries

Japan

References

Murakami M, Osada K, Mizuno H, Ochiai T, Alev L, Nishioka K. A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients. Arthritis Res Ther. 2015 Aug 22;17(1):224. doi: 10.1186/s13075-015-0718-y.

Reference Type: DERIVED

PMID: 26296539 (View on PubMed)

Other Identifiers

F1J-JE-HMGZ

Identifier Type: OTHER

Identifier Source: secondary_id

14377

Identifier Type: -

Identifier Source: org_study_id