A Study for Adult Patients With Fibromyalgia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00965081
• Date of registration: 24/08/2009
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study for Adult Patients With Fibromyalgia HMGG
• Scientific title: A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
• Date of first enrolment: September 2009
• Target sample size: 308
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00965081
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina, Israel, Mexico, Puerto Rico, United States

Contacts

• 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fibromyalgia, Primary

Fibromyalgia, Secondary

Intervention(s)

Drug: Duloxetine

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II) [Time Frame: Baseline, 12 weeks]

Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS) [Time Frame: Baseline through 12 weeks]

Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint [Time Frame: 12 weeks]

Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI) [Time Frame: Baseline, 12 weeks]

Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36) [Time Frame: Baseline, 12 weeks]

Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form [Time Frame: Baseline, 12 weeks]

Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ) [Time Frame: Baseline, 12 weeks]

Patient Global Impression - Improvement (PGI-I) at Endpoint [Time Frame: 12 weeks]

Secondary ID(s)

12873

F1J-MC-HMGG

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/11/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00965081