Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
NCT ID: NCT06860984
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
44 participants
INTERVENTIONAL
2025-03-10
2026-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
The patients will receive placebo capsule placebo tablet 2 h before ERCP.
Placebo capsule
Placebo will have the same look and appearance of active comparator
Duloxetine group
The patients will receive 60 mg duloxetine 2 h before ERCP.
Duloxetine
Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties
Interventions
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Duloxetine
Duloxetine, a non-opioid neuromodulator, has been widely used to manage neuropathic pain. It possesses dual central and peripheral analgesic properties
Placebo capsule
Placebo will have the same look and appearance of active comparator
Eligibility Criteria
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Inclusion Criteria
* Gender: 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
Exclusion Criteria
* Severe bleeding tendency
* Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min)
* Patients with severe heart disease.
* Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
* Currently pregnant or nursing
* Admission due to established pancreatitis before ECRP
* Unwillingness to undergo ERCP.
18 Years
65 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Mostafa Bahaa
Lecturer
Locations
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Tanta Unuversity
Tanta, , Egypt
Countries
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Facility Contacts
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Other Identifiers
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5487
Identifier Type: -
Identifier Source: org_study_id
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