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Pharmacological Prophylaxis of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

NCT03708458 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2018-10-18

No results posted yet for this study

Summary

The investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of post-ERCP pancreatitis, using pharmacologic agents with different mechanisms of action (NSAIDs and/or acetylcysteine) in three different regimens.

Conditions

  • Post-ERCP Pancreatitis

Interventions

DRUG

indomethacin suppository

the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

DRUG

N-acetylcysteine (NAC)

the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens

Sponsors & Collaborators

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • GHEORGHE BALAN, PhD, Professor · "GRIGORE T. POPA" UNIVERSITY OF MEDICINE AND PHARMACY IAŞI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-12-15
Completion
2018-12-15

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708458 on ClinicalTrials.gov