FibromyalgiaPhase 2NCT06752590
A Clinical Study of ONO-1110 in Patients With Fibromyalgia
A Phase 2 study testing ONO-1110 in people with Fibromyalgia, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.
Trial summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- ONO-1110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 30 sitesJapan
- Study dates
- 26 Mar 2025to 30 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Ai Sakura Clinic
Fukuoka, Fukuoka
Kyushu University Hospital
Fukuoka
Mayflower Hospital
Katō, Hyōgo
Kokorotoitami Clinic
Kawasaki, Kanagawa
Junwakai Memorial Hospital
Miyazaki, Miyazaki
Shirasawa Orthopedic Clinic
Morioka, Iwate
Aichi Medical University Hospital
Nagakute, Aichi-ken
Kimura Clinic
Nagoya, Aichi-ken
Medical Corporation Fujigaki Clinic
Ōita, Oita Prefecture
Japanese Red Cross Okayama Hospital
Okayama, Okayama-ken
Miyashita Rheumatology Clinic
Ōmura, Nagasaki
Hayaishi Hospital
Osaka, Osaka
Morimoto Clinic
Osaka, Osaka
Sapporo City General Hospital
Sapporo, Hokkaido
Shizuoka Rehab Pain Clinic
Shizuoka, Shizuoka
Fukuwa Clinic
Tokyo, Tokyo
Ginza Neurological Clinic
Tokyo, Tokyo
Himenotomomi Clinic
Tokyo, Tokyo
Ikebukuro Internal Medicine
Tokyo, Tokyo
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, Tokyo
Juntendo University Hospital
Tokyo, Tokyo
Juntendo University Nerima Hospital
Tokyo, Tokyo
Nihonbashi Medical
Tokyo, Tokyo
Nishiogi Pain Clinic
Tokyo, Tokyo
Sanno Hospital
Tokyo, Tokyo
Tokyo-Eki Center-Building Clinic
Tokyo, Tokyo
Yakushinkai Healthcare Association Kandasudacho Dermatology
Tokyo
Toyama University Hospital
Toyama, Toyama
Women's Clinic Luna
Yokohama, Kanagawa
National Hospital Organization Shimoshizu National Hospital
Yotsukaidō, Chiba
About this study
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
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
- Conditions
- Fibromyalgia
- Being tested
- ONO-1110, Placebo
- Keywords
- ONO-1110, ONO-1110-05, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-1110Drug
ONO-1110 tablets once a day
PlaceboDrug
Placebo tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| ONO-1110 | Experimental | ONO-1110 tablets once a day Receives: Drug: ONO-1110 |
| Placebo | Placebo comparator | Placebo tablets once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Adverse events
Measured: Up to 16 weeks
Secondary outcomes (10)
Change in weekly mean of average pain score from baseline in each week
Measured: Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score
proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively
Measured: Up to 16 weeks
Change in weekly mean of worst pain score from baseline to each week
Measured: Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score
proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively
Measured: Up to 16 weeks
Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline
Measured: Up to 16 weeks
Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline
Measured: Up to 16 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline
Measured: Up to 16 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
Measured: Up to 16 weeks
Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline
Measured: Up to 16 weeks
Plasma ONO-1110 concentrations
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start26 Mar 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752590
- Sponsor's protocol ID
- ONO-1110-05
- Other IDs
- jRCT2031240522
- Status last verified
- Jul 2026
- First submitted
- 22 Dec 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06752590
- Acronym / sponsor ID
- ONO-1110-05
- Conditions
- Fibromyalgia
- Keywords
- ONO-1110, ONO-1110-05, Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-1110 | Experimental | Drug: ONO-1110ONO-1110 tablets once a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-1110ONO-1110 tablets once a day | Drug | ONO-1110 |
| PlaceboPlacebo tablets once daily | Drug | Placebo |
Primary outcome
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Adverse events
Time frame: Up to 16 weeks
10 secondary outcomes
Change in weekly mean of average pain score from baseline in each week
Time frame: Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of average pain score
Time frame: Up to 16 weeks
Change in weekly mean of worst pain score from baseline to each week
Time frame: Up to 16 weeks
30%- and 50%-responder rates based on the weekly mean of worst pain score
Time frame: Up to 16 weeks
Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline
Time frame: Up to 16 weeks
Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline
Time frame: Up to 16 weeks
Change in Patient Global Impression of Change (PGIC) score from baseline
Time frame: Up to 16 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
Time frame: Up to 16 weeks
Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline
Time frame: Up to 16 weeks
Plasma ONO-1110 concentrations
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-1110 in people with Fibromyalgia, run by Ono Pharmaceutical Co., Ltd. at 30 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weekly mean of average pain score from baseline to Week 8 of the treatment period (time frame: Up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.