A Clinical Study of ONO-1110 in Patients With Fibromyalgia

Phase 2CompletedNCT06752590

Ono Pharmaceutical Co., Ltd.175 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

175

Conditions

Fibromyalgia

Interventions

ONO-1110DRUG

ONO-1110 tablets once a day

PlaceboDRUG

Placebo tablets once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (30)

Aichi Medical University Hospital

Nagakute, Aichi-ken, Japan

Outcomes

Primary Outcomes

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

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

proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively

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

proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively

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

Data from ClinicalTrials.gov

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