drugset / Trial / NCT06623513
Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis
Phase 2
Not yet recruiting
100 enrolled
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RandomizedParallel-groupSingle-blindPrevention
Summary
This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Indomethacin | Small molecule | 100 mg | Rectal |
| Subject | Parecoxib | Small molecule | 40 mg | Intravenous |