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A multicenter, open, prospective observational study to confirm the clinical efficacy and safety after drug change in patients with degenerative arthritis (spondyloarthritis, knee arthritis) treated with anti-inflammatory analgesics

A multicenter, open, prospective observational study to confirm the clinical efficacy and safety after drug change in patients with degenerative arthritis (spondyloarthritis, knee arthritis) treated with anti-inflammatory analgesics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007770
Enrollment
800
Registered
2022-10-06
Start date
2022-11-09
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor
Korea University Anam Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients over 19 years of age who have been diagnosed with degenerative arthritis, specifically spondyloarthritis or osteoarthritis of the knee, who have been prescribed non-selective NSAIDs for at least 4 weeks. 2) Patients who have not been given Cox2-selective NSAIDs in the treatment of degenerative arthritis within the last 2 weeks. 3) Patients confirmed to have symptomatic osteoarthritis through medical history, with a pain VAS score is greater than 40 mm prior to participant registration. 4) Individuals who voluntarily agree to participate in this study, who can understand the information provided to them, and who can sign the consent form willingly.

Exclusion criteria

Exclusion criteria: 1) A person diagnosed with a clinically significant mental illness and receiving medication. 2) Patients with severe gastrointestinal diseases (such as gastric ulcers) as judged by the investigator. 3) Patients with established ischemic heart disease, peripheral arterial disease, or cerebrovascular disease, or those with a high risk of severe cardiovascular adverse reactions (such as heart attack, myocardial infarction, stroke) as judged by the investigator. 4) Patients scheduled for surgery during the clinical trial period. 5) Patients with a history of allergies to any components of the clinical research medication. 6) Patients with malignant tumors or other serious health conditions that may result in a life expectancy of less than 6 months. 7) Patients who have participated in another clinical trial within the last 4 weeks prior to the study. 8) Participants who are unable to comply with the clinical research procedures specified in the study protocol. 9) Any other individuals deemed unsuitable for participation in this clinical research based on the medical opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
100mm Pain VAS Variation;EQ-5D-5L Variation

Secondary

MeasureTime frame
100mm Pain VAS Variation;EQ-5D-5L Variation;ODI change in case of osteoarthritis;K-WOMAC [22] change in case of gonarthritis;Overall drug discontinuation rate;drug discontinuation rate according to Satisfied with pain control;drug discontinuation rate according to AE;drug discontinuation rate according to insufficient effect

Countries

Korea, Republic of

Contacts

Public ContactSeonghwan Moon

Yonsei University Health System, Severance Hospital

shmoon@yuhs.ac+82-2-2228-2188

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026