ONO-1110-05:Phase IIa study of ONO-1110 in Patients with Fibromyalgia

JRCT ID: jRCT2031240522

Registered date:05/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Fibromyalgia
• Date of first enrollment: 27/01/2025
• Target sample size: 160
• Study type: Interventional

Intervention(s)

The IMP is administered as follows according to the assigned administration group.
- ONO-1110 group: Take ONO-1110 tablets once a day.
- Placebo group: Take placebo tablets once daily.

Outcome(s)

Primary Outcome

Efficacy:
Change in weekly mean of average pain score
Safety:
Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test

Secondary Outcome

-Efficacy
-Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Terasawa Tetsuji