Evaluating ONO-1110 for treating 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
PHASE2 · Ono Pharmaceutical Co. Ltd · NCT06752590
This study is testing if a new medication called ONO-1110 can help people with fibromyalgia feel less pain compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co. Ltd (industry) |
| Locations | 20 sites (Nagoya, Aichi and 19 other locations) |
| Trial ID | NCT06752590 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the efficacy and safety of ONO-1110 in patients diagnosed with fibromyalgia. Participants will be randomly assigned to receive either ONO-1110 or a placebo, with their pain levels monitored through diaries and questionnaires. The study focuses on Japanese outpatients who meet specific criteria set by the American College of Rheumatology for fibromyalgia. The goal is to determine if ONO-1110 can provide significant relief from fibromyalgia symptoms compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese outpatients who meet the American College of Rheumatology criteria for fibromyalgia.
Not a fit: Patients with inflammatory or autoimmune diseases, or those with other pain conditions that could interfere with study assessments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from fibromyalgia.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in exploring new treatments for fibromyalgia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Nagoya, Aichi and 19 other locations
- Kimura Clinic — Nagoya, Aichi, Japan (RECRUITING)
- National Hospital Organization Shimoshizu National Hospital — Yotsukaidō, Chiba, Japan (NOT_YET_RECRUITING)
- Sapporo City General Hospital — Sapporo, Hokkaido, Japan (NOT_YET_RECRUITING)
- Shirasawa Orthopedic Clinic — Morioka, Iwate, Japan (RECRUITING)
- Kokorotoitami Clinic — Kawasaki, Kanagawa, Japan (NOT_YET_RECRUITING)
- Miyashita Rheumatology Clinic — Ōmura, Nagasaki, Japan (NOT_YET_RECRUITING)
- Medical Corporation Fujigaki Clinic — Ōita, Oita, Japan (NOT_YET_RECRUITING)
- Ai Sakura Clinic — Fukuoka, Japan (RECRUITING)
- Japanese Red Cross Okayama Hospital — Okayama, Japan (NOT_YET_RECRUITING)
- Hayaishi Hospital — Osaka, Japan (RECRUITING)
- Morimoto Clinic — Osaka, Japan (RECRUITING)
- Shizuoka Rehab Pain Clinic — Shizuoka, Japan (NOT_YET_RECRUITING)
- Fukuwa Clinic — Tokyo, Japan (NOT_YET_RECRUITING)
- Ginza Neurological Clinic — Tokyo, Japan (NOT_YET_RECRUITING)
- Himenotomomi Clinic — Tokyo, Japan (NOT_YET_RECRUITING)
- Juntendo Tokyo Koto Geriatric Medical Center — Tokyo, Japan (NOT_YET_RECRUITING)
- Juntendo University Nerima Hospital — Tokyo, Japan (NOT_YET_RECRUITING)
- Nihonbashi Medical — Tokyo, Japan (NOT_YET_RECRUITING)
- Sanno Hospital — Tokyo, Japan (NOT_YET_RECRUITING)
- Tokyo-Eki Center-Building Clinic — Tokyo, Japan (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Ono Pharmaceutical Co., Ltd.
- Email: clinical_trial@ono-pharma.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, ONO-1110, ONO-1110-05