Clinical trial NCT00965081: A Study for Adult Patients With Fibromyalgia
Official title: A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia, Primary
Fibromyalgia, Secondary
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
timeFrame: Baseline, 12 weeks
measure: Patient Global Impression - Improvement (PGI-I) at Endpoint
timeFrame: 12 weeks
measure: Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
timeFrame: 12 weeks
measure: Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
timeFrame: Baseline, 12 weeks
measure: Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, 12 weeks
measure: Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline through 12 weeks
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: 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
country: Mexico
facility: 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
country: Mexico
facility: 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
country: Mexico
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: