A Clinical Study of ONO-1110 in Patients With Fibromyalgia

NCT ID: NCT06752590

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ONO-1110

ONO-1110 tablets once a day

Group Type EXPERIMENTAL

ONO-1110

Intervention Type DRUG

ONO-1110 tablets once a day

Placebo

Placebo tablets once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once daily

Interventions

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ONO-1110

ONO-1110 tablets once a day

Intervention Type DRUG

Placebo

Placebo tablets once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

Site Status RECRUITING

Kimura Clinic

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

National Hospital Organization Shimoshizu National Hospital

Yotsukaidō, Chiba, Japan

Site Status RECRUITING

Sapporo City General Hospital

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Shirasawa Orthopedic Clinic

Morioka, Iwate, Japan

Site Status RECRUITING

Kokorotoitami Clinic

Kawasaki, Kanagawa, Japan

Site Status RECRUITING

Women's Clinic Luna

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Miyashita Rheumatology Clinic

Ōmura, Nagasaki, Japan

Site Status RECRUITING

Medical Corporation Fujigaki Clinic

Ōita, Oita Prefecture, Japan

Site Status RECRUITING

Ai Sakura Clinic

Fukuoka, , Japan

Site Status RECRUITING

Kyushu University Hospital

Fukuoka, , Japan

Site Status RECRUITING

Japanese Red Cross Okayama Hospital

Okayama, , Japan

Site Status RECRUITING

Hayaishi Hospital

Osaka, , Japan

Site Status RECRUITING

Morimoto Clinic

Osaka, , Japan

Site Status RECRUITING

Shizuoka Rehab Pain Clinic

Shizuoka, , Japan

Site Status RECRUITING

Fukuwa Clinic

Tokyo, , Japan

Site Status RECRUITING

Ginza Neurological Clinic

Tokyo, , Japan

Site Status RECRUITING

Himenotomomi Clinic

Tokyo, , Japan

Site Status RECRUITING

Ikebukuro Internal Medicine

Tokyo, , Japan

Site Status RECRUITING

Juntendo Tokyo Koto Geriatric Medical Center

Tokyo, , Japan

Site Status RECRUITING

Juntendo University Hospital

Tokyo, , Japan

Site Status RECRUITING

Juntendo University Nerima Hospital

Tokyo, , Japan

Site Status RECRUITING

Nihonbashi Medical

Tokyo, , Japan

Site Status RECRUITING

Nishiogi Pain Clinic

Tokyo, , Japan

Site Status RECRUITING

Sanno Hospital

Tokyo, , Japan

Site Status RECRUITING

Tokyo-Eki Center-Building Clinic

Tokyo, , Japan

Site Status RECRUITING

Yakushinkai Healthcare Association Kandasudacho Dermatology

Tokyo, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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North America Clinical Trial Support Desk

Role: CONTACT

+18665877745(Toll-Free)

International Clinical Trial Support Desk

Role: CONTACT

+17162141777(Standard)

Other Identifiers

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jRCT2031240522

Identifier Type: REGISTRY

Identifier Source: secondary_id

ONO-1110-05

Identifier Type: -

Identifier Source: org_study_id

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