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Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111707
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Rectal indomethacin 100mg one time before or after ERCP Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 534 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
Actual Study Start Date : April 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: Rectal Indomethacin pre-ERCP
Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).
Drug: Rectal indomethacin 100mg one time before or after ERCP
Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
Other Name: Indocid 100mg

Active Comparator: Rectal Indomethacin post-ERCP
Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
Drug: Rectal indomethacin 100mg one time before or after ERCP
Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
Other Name: Indocid 100mg




Primary Outcome Measures :
  1. Rate of Post-ERCP pancreatitis [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Severity of Post-ERCP pancreatitis [ Time Frame: 30 days ]
    To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients referred for ERCP at the University of Alberta
  • Age greater than 18 years
  • Ability to provide written informed consent

Exclusion Criteria:

  • Acute pancreatitis
  • Active peptic ulcer disease
  • Rectal disease
  • Aspirin-induced asthma
  • Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
  • Pregnancy
  • Breast feeding
  • Creatinine clearance < 30 ml/min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111707


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G2X8
Sponsors and Collaborators
University of Alberta
Publications of Results:
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02111707    
Other Study ID Numbers: Pro00041158
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action