Study of Duloxetine to Prevent Pancreatitis After Endoscopic Retrograde Cholangiopancreatography ERCP in Adults with Biliary Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of duloxetine in preventing pancreatitis after undergoing endoscopic retrograde cholangiopancreatography ERCP, a key procedure used to diagnose and treat pancreato-biliary diseases. Post-ERCP pancreatitis PEP is a common and serious complication that can lead to significant health problems. This Phase 3 randomized, double-blind study aims to compare duloxetine with a placebo to see if it can reduce the risk of PEP in adults up to 65 years old. Participants will be randomly assigned to receive either a 60 mg dose of duloxetine or a placebo capsule two hours before the ERCP procedure. Duloxetine is a non-opioid drug known for managing neuropathic pain and has both central and peripheral analgesic effects. The placebo is designed to look identical to duloxetine to maintain blinding. Patients will be monitored closely during and after the procedure to assess outcomes. During the study, researchers will observe whether pancreatitis develops within 24 hours after ERCP, which is the primary outcome being measured. Participants must have normal blood amylase and lipase levels before the procedure. The study includes monitoring for safety and adverse effects during the follow-up period. The total participation duration is based on the timing around the ERCP procedure and the subsequent 24-hour monitoring window.

Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis