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A Clinical Study of ONO-1110 in Patients With Fibromyalgia
A Clinical Study of ONO-1110 in Patients With Fibromyalgia

NCT06752590

CompletedPhase 2

Sponsor: Ono Pharmaceutical Co., Ltd.

Conditions: Fibromyalgia

Interventions: ONO-1110, Placebo

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (30)
  • Nagakute, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Yotsukaidō, Chiba, Japan
  • Fukuoka, Fukuoka, Japan
  • Sapporo, Hokkaido, Japan
  • Katō, Hyōgo, Japan
  • Morioka, Iwate, Japan
  • Kawasaki, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Miyazaki, Miyazaki, Japan
  • Ōmura, Nagasaki, Japan
  • Ōita, Oita Prefecture, Japan
  • Okayama, Okayama-ken, Japan
  • Osaka, Osaka, Japan
  • Osaka, Osaka, Japan
  • Shizuoka, Shizuoka, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Tokyo, Tokyo, Japan
  • Toyama, Toyama, Japan
  • Fukuoka, Japan
  • Tokyo, Japan