Fibromyalgia
Conditions
Keywords
ONO-1110, ONO-1110-05, Fibromyalgia
Brief summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia
Interventions
DRUGONO-1110
ONO-1110 tablets once a day
DRUGPlacebo
Placebo tablets once daily
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weekly mean of average pain score from baseline to Week 8 of the treatment period | Up to 16 weeks |
| Adverse events | Up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weekly mean of average pain score from baseline in each week | Up to 16 weeks | — |
| 30%- and 50%-responder rates based on the weekly mean of average pain score | Up to 16 weeks | proportions of participants whose weekly mean of average pain score has decreased by 30% and 50% from baseline, respectively |
| Change in weekly mean of worst pain score from baseline to each week | Up to 16 weeks | — |
| 30%- and 50%-responder rates based on the weekly mean of worst pain score | Up to 16 weeks | proportions of participants whose weekly mean of worst pain score has decreased by 30% and 50% from baseline, respectively |
| Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline | Up to 16 weeks | — |
| Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline | Up to 16 weeks | — |
| Change in Patient Global Impression of Change (PGIC) score from baseline | Up to 16 weeks | — |
| Change in Hospital Anxiety and Depression Scale (HADS) score from baseline | Up to 16 weeks | — |
| Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline | Up to 16 weeks | — |
| Plasma ONO-1110 concentrations | Up to 16 weeks | — |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed