Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

Treatment Details

Interventions

• Duloxetine (Serotonin-Norepinephrine Reuptake Inhibitor)

Duloxetine is already approved in Canada for the following indications:

Approved in Canada as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+