NCT01784445

Post ERCP Pancreatitis Prevention in Average Risk Patients

Diclophenac Potassium Versus Ceftazidime for Reduction of Post ERCP Pancreatitis in Average Risk Patients-double Blind, Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University Hospital Rijeka · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Diclophenac potassium and ceftazidime are commercially available drugs that are used in various clinical situations. They are safe and known for years. Diclophenac potassium and Ceftazidime have been used in some studies for the prophylaxis and treatment of pancreatitis and Post-ERCP Pancreatitis (PEP). Diclophenac potassium, together with indometacin is currently standard treatment for prevention of (PEP) while ceftazidime is possible alternative treatment for patients with contraindications for nonsteroidal medicines. The aim of the study is to evaluate the efficacy of Ceftazidime for the prophylaxis of PEP.

Detailed description

Study type: Interventional Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: only Investigator Primary Purpose: Prevention Study Phase: Phase 4 Conditions or Focus of the study: Post ERCP pancreatitis Intervention information * Intervention Names ERCP * Arm Information * Arm 1:Ceftazidime * Arm 2 (active comparator): Diclophenac potassium

Conditions

• Pancreatitis

Interventions

Type	Name	Description
DRUG	Ceftazidime	Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2015-02-01
• First posted: 2013-02-05
• Last updated: 2015-04-08

Locations

1 site across 1 country: Croatia