A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Last updated: February 19, 2025
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Fibromyalgia

Treatment

Placebo

ONO-1110

Clinical Study ID

NCT06752590
ONO-1110-05
jRCT2031240522
  • Ages > 18
  • All Genders

Study Summary

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Japanese (both sexes)

  • Outpatient

  • Patients who are considered capable of understanding the study procedures andcompleting the pain diary and questionnaires appropriately by the investigator (sub-investigator)

  • Patients who meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion

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 affectassessments 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 becomepregnant during the study period.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 01, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Kimura Clinic

    Nagoya, Aichi
    Japan

    Active - Recruiting

  • National Hospital Organization Shimoshizu National Hospital

    Yotsukaidō, Chiba
    Japan

    Site Not Available

  • Sapporo City General Hospital

    Sapporo, Hokkaido
    Japan

    Site Not Available

  • Shirasawa Orthopedic Clinic

    Morioka, Iwate
    Japan

    Active - Recruiting

  • Kokorotoitami Clinic

    Kawasaki, Kanagawa
    Japan

    Site Not Available

  • Miyashita Rheumatology Clinic

    Ōmura, Nagasaki
    Japan

    Site Not Available

  • Medical Corporation Fujigaki Clinic

    Ōita, Oita
    Japan

    Site Not Available

  • Ai Sakura Clinic

    Fukuoka,
    Japan

    Active - Recruiting

  • Japanese Red Cross Okayama Hospital

    Okayama,
    Japan

    Site Not Available

  • Hayaishi Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Morimoto Clinic

    Osaka,
    Japan

    Active - Recruiting

  • Shizuoka Rehab Pain Clinic

    Shizuoka,
    Japan

    Site Not Available

  • Fukuwa Clinic

    Tokyo,
    Japan

    Site Not Available

  • Ginza Neurological Clinic

    Tokyo,
    Japan

    Site Not Available

  • Himenotomomi Clinic

    Tokyo,
    Japan

    Site Not Available

  • Juntendo Tokyo Koto Geriatric Medical Center

    Tokyo,
    Japan

    Site Not Available

  • Juntendo University Nerima Hospital

    Tokyo,
    Japan

    Site Not Available

  • Nihonbashi Medical

    Tokyo,
    Japan

    Site Not Available

  • Sanno Hospital

    Tokyo,
    Japan

    Site Not Available

  • Tokyo-Eki Center-Building Clinic

    Tokyo,
    Japan

    Site Not Available

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