- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00965081
A Study for Adult Patients With Fibromyalgia (HMGG)
A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Guadalajara, Mexico, 45040
- 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.
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Merida, Mexico, 97000
- 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.
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Monterrey, Mexico, 64040
- 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.
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Morelia, Mexico, 58000
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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QD po at the same time each day for 12 weeks
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Experimental: Duloxetine
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30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Patient Global Impression - Improvement (PGI-I) at Endpoint
Time Frame: 12 weeks
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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).
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12 weeks
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Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
Time Frame: 12 weeks
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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). |
12 weeks
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Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
Time Frame: Baseline, 12 weeks
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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. |
Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline through 12 weeks
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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. |
Baseline through 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- 12873
- F1J-MC-HMGG (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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