Actively Recruiting
Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Led by Tanta University ยท Updated on 2025-11-18
44
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age more than 18 years old
- Both males and females
- Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders
- Blood amylase and lipase levels before ERCP are within the normal limits
You will not qualify if you...
- Uncontrolled diabetes mellitus
- Severe bleeding tendency
- Impaired renal function (serum creatinine > 2 mg/dL or creatinine clearance <30 ml/min)
- Patients with severe heart disease
- Prior biliary or pancreatic sphincterotomy, dilatation, or stenting of either duct
- Currently pregnant or nursing
- Admission due to established pancreatitis before ERCP
- Unwillingness to undergo ERCP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants receive either 60 mg duloxetine or a placebo capsule 2 hours before undergoing the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
1 visit (in-person)
Duration - 24 hours
Participants are monitored for development of pancreatitis and other outcomes after the procedure.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Tanta Unuversity
Tanta, Egypt, 31527
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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