A Study for Adult Patients With Fibromyalgia (HMGG)

Lilly

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia, Secondary; Fibromyalgia, Primary

Treatments: Drug: Placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965081

F1J-MC-HMGG (Other Identifier)

12873

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

308 participants in 2 patient groups, including a placebo group

Duloxetine

Experimental group

Treatment:

Drug: Duloxetine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo