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Completed

NCT Number: NCT06752590

A Clinical Study of ONO-1110 in Patients With Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Medical University Hospital, Nagakute, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ONO-1110

Drug

ONO-1110 tablets once a day

Placebo

Drug

Placebo tablets once daily

Primary outcomes

  1. Change in weekly mean of average pain score from baseline to Week 8 of the treatment period

    Time frame: Up to 16 weeks

  2. Adverse events

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Change in weekly mean of average pain score from baseline in each week

    Time frame: Up to 16 weeks

  2. 30%- and 50%-responder rates based on the weekly mean of average pain score

    Time frame: Up to 16 weeks

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

  3. Change in weekly mean of worst pain score from baseline to each week

    Time frame: Up to 16 weeks

  4. 30%- and 50%-responder rates based on the weekly mean of worst pain score

    Time frame: Up to 16 weeks

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

  5. Change in WPI and SSS score of 2016 Revised FM Diagnostic Criteria by ACR from baseline

    Time frame: Up to 16 weeks

  6. Change in Japanese version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) score from baseline

    Time frame: Up to 16 weeks

  7. Change in Patient Global Impression of Change (PGIC) score from baseline

    Time frame: Up to 16 weeks

  8. Change in Hospital Anxiety and Depression Scale (HADS) score from baseline

    Time frame: Up to 16 weeks

  9. Change in Medical Outcomes Study Sleep Scale (MOS-Sleep Scale) score from baseline

    Time frame: Up to 16 weeks

  10. Plasma ONO-1110 concentrations

    Time frame: Up to 16 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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