A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia

The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: duloxetine hydrochloride; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 530
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Hato Rey, Puerto Rico, 00918
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  • Ponce, Puerto Rico, 00716
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  • San Juan, Puerto Rico, 00935
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• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
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    • Tucson, Arizona, United States, 85741
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  • California
    • Los Angeles, California, United States, 90024
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    • Pasadena, California, United States, 91105
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  • Connecticut
    • Cromwell, Connecticut, United States, 06416
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    • Danbury, Connecticut, United States, 06810
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  • Florida
    • Bradenton, Florida, United States, 34208
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    • Deland, Florida, United States, 32720
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    • Fort Myers, Florida, United States, 33912
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    • Orlando, Florida, United States, 32806
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    • South Miami, Florida, United States, 33143
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    • Tampa, Florida, United States, 33606
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    • West Palm Beach, Florida, United States, 33407
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  • Illinois
    • Oak Brook, Illinois, United States, 60523
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  • Indiana
    • Lafayette, Indiana, United States, 47905
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  • Kansas
    • Prairie Village, Kansas, United States, 66206
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  • Maryland
    • Rockville, Maryland, United States, 20852
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  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
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    • Fall River, Massachusetts, United States, 02721
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    • Newton, Massachusetts, United States, 02462
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    • Springfield, Massachusetts, United States, 01103
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  • Michigan
    • Ann Arbor, Michigan, United States, 48104
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  • Missouri
    • St Louis, Missouri, United States, 63141
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  • New Jersey
    • Edison, New Jersey, United States, 08817
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    • Piscataway, New Jersey, United States, 08854
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  • North Carolina
    • Greensboro, North Carolina, United States, 27408
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  • Ohio
    • Cincinnati, Ohio, United States, 45219
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    • Toledo, Ohio, United States, 43623
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • 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.
  • Oregon
    • Eugene, Oregon, United States, 97404
      • 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.
    • Portland, Oregon, United States, 97210
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  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • 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.
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • 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.
  • Texas
    • Dallas, Texas, United States, 75231
      • 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.
    • Lake Jackson, Texas, United States, 77566
      • 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.
    • San Antonio, Texas, United States, 78229
      • 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.
    • Waco, Texas, United States, 76708
      • 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.
    • Wichita Falls, Texas, United States, 76309
      • 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.
  • Utah
    • West Jordan, Utah, United States, 84088
      • 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.
  • Washington
    • Bellevue, Washington, United States, 98007
      • 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.
    • Seattle, Washington, United States, 98104
      • 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.
    • Tacoma, Washington, United States, 98405
      • 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.
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female patients
• aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
• have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
• all females must test negative for pregnancy at the time of enrollment
• have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.

Exclusion Criteria:

• have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
• have regional pain syndrome, multiple surgeries or failed back syndrome
• have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duloxetine; 60-120 mg, oral, every day, 12 weeks	Drug: duloxetine hydrochloride; 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).; Other Names: Cymbalta; LY248686
Placebo Comparator: Placebo; oral, daily, 12 weeks	Drug: placebo; oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's Global Impressions of Improvement (PGI-I) at Week 12	The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint	BPI is a self-reported form that assesses severity of pain and the interference of pain on function. There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Interference scores range from 0 (does not interfere) to 10 (completely interferes).	Baseline, 12 weeks
Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint	MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension. Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.	Baseline, 12 weeks
Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint	BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.	Baseline, 12 weeks
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint	The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).	Baseline, 12 Weeks
Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint	BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.	Baseline, 12 weeks
Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks	The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.	Baseline, 12 weeks
Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint	The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being. Each question is rated 1 = "greater than normal" to 6 = "totally absent". Total score ranges from 7 to 42.	Baseline, 12 weeks
Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint	Likert scales are patient-rated assessments. Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed. Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious. Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered. Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered. Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.	Baseline, 12 weeks
Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint	Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).	12 Weeks
Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint	Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score. BPI average pain score assesses the severity of the average pain in the past 24 hours. The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).	12 weeks
Change From Baseline in Blood Pressure at 12 Week Endpoint		Baseline, 12 weeks
Change From Baseline in Heart Rate at 12 Week Endpoint		Baseline, 12 weeks
Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)	C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of patients with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide.	Baseline through 12 Weeks
Change From Baseline in Weight at 12 Week Endpoint		Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Boehringer Ingelheim

Publications and helpful links

General Publications

• Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
• Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
• Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.

Helpful Links

• Lilly Clinical Trials Registry

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: May 5, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 7, 2008

Study Record Updates

• Last Update Posted (Estimate): June 24, 2010
• Last Update Submitted That Met QC Criteria: May 28, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: 12220 (Other Identifier: Company Internal); F1J-US-HMGB (Other Identifier: Eli Lilly and Company)