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ONO-1110-05:A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

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

Terasawa Tetsuji

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Complete

Mar. 14, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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.

Both

Fibromyalgia

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.

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

-Efficacy
-Pharmacokinetics

+81-3-5543-0196

Dec. 12, 2024

No

none