A Phase 4 interventional study of Ceftazidime in Pancreatitis, sponsored by University Hospital Rijeka. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by University Hospital Rijeka · Phase 4, Interventional, and Prevention
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.
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
Arm Information
759 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 450 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →University Hospital Rijeka is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
o Unwillingness or inability to consent for the study
Procedure/Surgery: ERCP Each patient will receive: Ceftazidime 2 g i.v. once daily 30 minutes prior to procedure and glycerin suppository as placebo
Drug: Ceftazidime
Procedure/Surgery:ERCP Each patient will receive 100 mg Diclophenac suppositories, once daily immediately prior to procedure plus 100 ml of saline as placebo
Drug: Ceftazidime
Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure
Also known as: Fortaz
Incidence of PEP in the group of patients receiving Ceftazidime versus incidence of PEP in the group of patients receiving Diclophenac potassium
Time frame: One year
Time to discharge from hospital
Influence of PEP severity on time to discharge from hospital
Time frame: One year
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ceftazidime
University Hospital Rijeka