CompletedPhase 2
A Clinical Study of ONO-1110 in Patients With Fibromyalgia
Key facts
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Where
- Japan30 sites in 1 countryChoose a country to see its sites
- Trial code
- NCT06752590
- JRCT2031240522
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 175 people enrolled
- Started
- 26 Mar 2025
- Ended
- 30 May 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ONO-1110
- Placebo
- Record updated
- 7 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 with inflammatory arthritis, infectious arthritis, or autoimmune disease
- Patients with pain other than FM that may affect assessments in this study
- Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
The 2 groups in the trial
- ONO-1110Treatment being tested
ONO-1110 tablets once a day
- PlaceboPlacebo, for comparison
Placebo tablets once daily
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 7 July 2026