Back to resultsDuloxetine Versus Placebo for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
duloxetine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria:
- Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
- Abnormal thyroid-stimulating hormone concentrations.
Sites / 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.
Outcomes
Primary Outcome Measures
To assess efficacy of duloxetine 60 mg twice daily (BID) compared with placebo on reduction of pain severity, measured by average pain item of Brief Pain Inventory (BPI) in patients with ACR-defined primary fibromyalgia, with or without major depression.
Secondary Outcome Measures
To evaluate the efficacy of duloxetine 60 mg once daily (QD) compared with placebo during a 12-week, double-blind, acute therapy phase on the reduction of pain severity as measured by the average pain item of the Brief Pain Inventory (BPI).
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of the area under the curve of pain relief as derived from BPI average pain score
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Fibromyalgia Impact Questionnaire (FIQ) total score
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on improvement of Brief Pain Inventory (BPI) severity (worst pain, least pain, pain right now) and interference scores
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Tender point pain thresholds: mean thresholds and number of points with a low threshold
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Clinical Global Impression of Severity (CGI)
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Patient Global Impression of Improvement (PGI)
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Hamilton Depression 17- item Rating Scale (HAMD17) total score
To demonstrate that the effect of duloxetine 60 mg QD and duloxetine 60 mg BID on the BPI average pain score is independent of the presence or absence of a major depressive disorder (MDD) as defined by DSM-IV.
To evaluate whether improvement in pain severity (assessed by BPI average pain score) is direct analgesic effect of duloxetine therapy and independent of treatment effect on mood improvement, as measured by total score of HAMD17
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00489073
Brief Title
Duloxetine Versus Placebo for Fibromyalgia
Official Title
Duloxetine Versus Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
345 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
duloxetine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
To assess efficacy of duloxetine 60 mg twice daily (BID) compared with placebo on reduction of pain severity, measured by average pain item of Brief Pain Inventory (BPI) in patients with ACR-defined primary fibromyalgia, with or without major depression.
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of duloxetine 60 mg once daily (QD) compared with placebo during a 12-week, double-blind, acute therapy phase on the reduction of pain severity as measured by the average pain item of the Brief Pain Inventory (BPI).
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of the area under the curve of pain relief as derived from BPI average pain score
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Fibromyalgia Impact Questionnaire (FIQ) total score
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on improvement of Brief Pain Inventory (BPI) severity (worst pain, least pain, pain right now) and interference scores
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Tender point pain thresholds: mean thresholds and number of points with a low threshold
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Clinical Global Impression of Severity (CGI)
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Patient Global Impression of Improvement (PGI)
Title
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Hamilton Depression 17- item Rating Scale (HAMD17) total score
Title
To demonstrate that the effect of duloxetine 60 mg QD and duloxetine 60 mg BID on the BPI average pain score is independent of the presence or absence of a major depressive disorder (MDD) as defined by DSM-IV.
Title
To evaluate whether improvement in pain severity (assessed by BPI average pain score) is direct analgesic effect of duloxetine therapy and independent of treatment effect on mood improvement, as measured by total score of HAMD17
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.
Exclusion Criteria:
Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
Abnormal thyroid-stimulating hormone concentrations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Duloxetine Versus Placebo for Fibromyalgia
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