A Clinical Study of ONO-1110 in Patients With Fibromyalgia
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
2 other identifiers
interventional
160
1 country
30
Brief Summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2024
CompletedFirst Posted
Study publicly available on registry
December 30, 2024
CompletedStudy Start
First participant enrolled
March 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 25, 2026
March 1, 2026
1.3 years
December 22, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
Up to 16 weeks
Adverse events
Up to 16 weeks
Secondary Outcomes (10)
Change in weekly mean of average pain score from baseline in each week
Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score
Up to 16 weeks
Change in weekly mean of worst pain score from baseline to each week
Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score
Up to 16 weeks
Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline
Up to 16 weeks
- +5 more secondary outcomes
Study Arms (2)
ONO-1110
EXPERIMENTALONO-1110 tablets once a day
Placebo
PLACEBO COMPARATORPlacebo tablets once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Kimura Clinic
Nagoya, Aichi-ken, Japan
National Hospital Organization Shimoshizu National Hospital
Yotsukaidō, Chiba, Japan
Ai Sakura Clinic
Fukuoka, Fukuoka, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Mayflower Hospital
Katō, Hyōgo, Japan
Shirasawa Orthopedic Clinic
Morioka, Iwate, Japan
Kokorotoitami Clinic
Kawasaki, Kanagawa, Japan
Women's Clinic Luna
Yokohama, Kanagawa, Japan
Junwakai Memorial Hospital
Miyazaki, Miyazaki, Japan
Miyashita Rheumatology Clinic
Ōmura, Nagasaki, Japan
Medical Corporation Fujigaki Clinic
Ōita, Oita Prefecture, Japan
Japanese Red Cross Okayama Hospital
Okayama, Okayama-ken, Japan
Hayaishi Hospital
Osaka, Osaka, Japan
Morimoto Clinic
Osaka, Osaka, Japan
Shizuoka Rehab Pain Clinic
Shizuoka, Shizuoka, Japan
Fukuwa Clinic
Tokyo, Tokyo, Japan
Ginza Neurological Clinic
Tokyo, Tokyo, Japan
Himenotomomi Clinic
Tokyo, Tokyo, Japan
Ikebukuro Internal Medicine
Tokyo, Tokyo, Japan
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Tokyo, Japan
Juntendo University Hospital
Tokyo, Tokyo, Japan
Juntendo University Nerima Hospital
Tokyo, Tokyo, Japan
Nihonbashi Medical
Tokyo, Tokyo, Japan
Nishiogi Pain Clinic
Tokyo, Tokyo, Japan
Sanno Hospital
Tokyo, Tokyo, Japan
Tokyo-Eki Center-Building Clinic
Tokyo, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Kyushu University Hospital
Fukuoka, Japan
Yakushinkai Healthcare Association Kandasudacho Dermatology
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2024
First Posted
December 30, 2024
Study Start
March 26, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share