Back to resultsA Study for Adult Patients With Fibromyalgia (HMGG)
Primary Purpose
Fibromyalgia, Primary, Fibromyalgia, Secondary
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia, Primary
Eligibility Criteria
Inclusion Criteria:
- Meet study criteria for fibromyalgia diagnosis.
Exclusion Criteria:
- Have previously or are currently taking duloxetine.
- Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
- Have pain symptoms that are difficult to differentiate from fibromyalgia.
- Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
- Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
- Are pregnant or breast-feeding
- Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
- Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
- Have a serious unstable medical illness
- Have a history of substance abuse or dependence within the past year
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.
- 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.
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Duloxetine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
Secondary Outcome Measures
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.
Patient Global Impression - Improvement (PGI-I) at Endpoint
The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is "very much better," 4 is "no change," and 7 is "very much worse." Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S).
Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).
The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S).
Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation.
Full Information
NCT ID
NCT00965081
First Posted
August 24, 2009
Last Updated
September 28, 2011
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00965081
Brief Title
A Study for Adult Patients With Fibromyalgia
Acronym
HMGG
Official Title
A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Primary, Fibromyalgia, Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta, LY248686
Intervention Description
30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
QD po at the same time each day for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
Description
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Description
BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.
Time Frame
Baseline, 12 weeks
Title
Patient Global Impression - Improvement (PGI-I) at Endpoint
Description
The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is "very much better," 4 is "no change," and 7 is "very much worse." Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S).
Time Frame
12 weeks
Title
Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
Description
The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).
The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S).
Time Frame
12 weeks
Title
Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
Description
The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
Description
FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
Description
The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Time Frame
Baseline, 12 weeks
Title
Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Description
SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.
Time Frame
Baseline, 12 weeks
Title
Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation.
Time Frame
Baseline through 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet study criteria for fibromyalgia diagnosis.
Exclusion Criteria:
Have previously or are currently taking duloxetine.
Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
Have pain symptoms that are difficult to differentiate from fibromyalgia.
Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
Are pregnant or breast-feeding
Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
Have a serious unstable medical illness
Have a history of substance abuse or dependence within the past year
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
Guadalajara
ZIP/Postal Code
45040
Country
Mexico
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
Merida
ZIP/Postal Code
97000
Country
Mexico
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
Monterrey
ZIP/Postal Code
64040
Country
Mexico
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
Morelia
ZIP/Postal Code
58000
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study for Adult Patients With Fibromyalgia
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