Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia

Eli Lilly and Company1 site in 1 country530 target enrollmentJune 2008

ConditionsFibromyalgia

Interventionsduloxetine hydrochloride placebo

Drugsduloxetine hydrochloride placebo

Overview

Phase: Phase 4
Intervention: duloxetine hydrochloride
Conditions: Fibromyalgia
Sponsor: Eli Lilly and Company
Enrollment: 530
Locations: 1
Primary Endpoint: Patient's Global Impressions of Improvement (PGI-I) at Week 12
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2008

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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)

Arms & Interventions

Duloxetine

60-120 mg, oral, every day, 12 weeks

Intervention: duloxetine hydrochloride

Placebo

oral, daily, 12 weeks

Intervention: placebo

Outcomes

Primary Outcomes

Patient's Global Impressions of Improvement (PGI-I) at Week 12

Time Frame: 12 weeks

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."

Secondary Outcomes

Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint(Baseline, 12 weeks)
Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint(Baseline, 12 Weeks)
Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint(Baseline, 12 weeks)
Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks(Baseline, 12 weeks)
Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint(Baseline, 12 weeks)
Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint(Baseline, 12 weeks)
Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint(12 Weeks)
Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint(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)(Baseline through 12 Weeks)
Change From Baseline in Weight at 12 Week Endpoint(Baseline, 12 weeks)