Clinical trial NCT06752590: A Clinical Study of ONO-1110 in Patients With Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: ONO-1110
ONO-1110-05
Fibromyalgia
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change in weekly mean of average pain score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Adverse events
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change in weekly mean of average pain score from baseline in each week
timeFrame: Up to 16 weeks
measure: 30%- and 50%-responder rates based on the weekly mean of average pain score
timeFrame: Up to 16 weeks
measure: Change in weekly mean of worst pain score from baseline to each week
timeFrame: Up to 16 weeks
measure: 30%- and 50%-responder rates based on the weekly mean of worst pain score
timeFrame: Up to 16 weeks
measure: Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline
timeFrame: Up to 16 weeks
measure: Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline
timeFrame: Up to 16 weeks
measure: Change in Patient Global Impression of Change (PGIC) score from baseline
timeFrame: Up to 16 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
timeFrame: Up to 16 weeks
measure: Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline
timeFrame: Up to 16 weeks
measure: Plasma ONO-1110 concentrations
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Kimura Clinic
state: Aichi
city: Yotsukaidō
country: Japan
facility: National Hospital Organization Shimoshizu National Hospital
state: Chiba
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Morioka
country: Japan
facility: Shirasawa Orthopedic Clinic
state: Iwate
city: Kawasaki
country: Japan
facility: Kokorotoitami Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Women's Clinic Luna
state: Kanagawa
city: Ōmura
country: Japan
facility: Miyashita Rheumatology Clinic
state: Nagasaki
city: Ōita
country: Japan
facility: Medical Corporation Fujigaki Clinic
state: Oita
city: Fukuoka
country: Japan
facility: Ai Sakura Clinic
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Osaka
country: Japan
facility: Hayaishi Hospital
city: Osaka
country: Japan
facility: Morimoto Clinic
city: Shizuoka
country: Japan
facility: Shizuoka Rehab Pain Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Ginza Neurological Clinic
city: Tokyo
country: Japan
facility: Himenotomomi Clinic
city: Tokyo
country: Japan
facility: Ikebukuro Internal Medicine
city: Tokyo
country: Japan
facility: Juntendo Tokyo Koto Geriatric Medical Center
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Nerima Hospital
city: Tokyo
country: Japan
facility: Nihonbashi Medical
city: Tokyo
country: Japan
facility: Nishiogi Pain Clinic
city: Tokyo
country: Japan
facility: Sanno Hospital
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-Building Clinic
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: