A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: ONO-1110; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06752590

ONO-1110-05

jRCT2031240522 (Registry Identifier)

Details and patient eligibility

About

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese (both sexes)
• Outpatient
• Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
• Patients who meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion criteria

• Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease
• Patients with pain other than FM that may affect assessments in this study
• Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
• Patients with a past history of or concurrent malignant tumor within 3 years
• Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups, including a placebo group

ONO-1110

Experimental group

Description:

ONO-1110 tablets once a day

Treatment:

Drug: ONO-1110

Placebo

Placebo Comparator group

Description:

Placebo tablets once daily

Treatment:

Drug: Placebo