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A simulated target trial of the safety assessment of selective versus non-selective non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis

A simulated target trial of the safety assessment of selective versus non-selective non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094051
Enrollment
Unknown
Registered
2024-12-16
Start date
2024-12-17
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

Knee osteoarthritis

Interventions

Study group:Celecoxib taken orally
Control group:Non-selective NSAIDs

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age greater than or equal to 18 years old; 2) Diagnosed with significant osteoarthritis or rheumatoid arthritis for at least three months; 3) continuous NSAIDs therapy (>= 6 months).

Exclusion criteria

Exclusion criteria: 1) Accompanied by ischemic heart disease, heart failure, peripheral arterial disease, cerebrovascular disease, gastrointestinal bleeding or active gastroduodenal ulcer and inflammatory bowel disease within 90 days before screening; 2) simultaneous use of antiplatelet or anticoagulants; 3) kidney, hepatic or coagulation dysfunction; 4) with malignant tumor (unless surgically resected and no recurrence within 5 years); 5) history of gastric or duodenal surgery (non-gastric suture); 6) Pregnant or lactating females.

Design outcomes

Primary

MeasureTime frame
Whether upper and/or lower GI events have occurred;Change from baseline in hematocrit;Whether there is a clinically significant decrease in hematocrit and/or hemoglobin from baseline;? Liver AEs in glutamyl transferase (GGT), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) at 3 times the upper limit of normal;Change from baseline in C-reactive protein;

Secondary

MeasureTime frame
Change from baseline in hemoglobin;

Countries

China

Contacts

Public ContactZhu Hongyi

Shanghai Sixth People's Hospital

420308955@qq.com+86 189 3017 0316

Outcome results

None listed

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