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Sponsored by: |
Queen's University |
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Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00428025 |
Inflammation of the pancreas (pancreatitis) is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized endoscopic examination of the ducts draining the liver and pancreas. Although many different strategies have been tried and studied in attempts to reduce this risk, few have been shown to make a significant difference. Those that have are either very expensive, difficult to administer, or both. Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure to patients at most risk for the complication, and has few side effects. This study will randomize people in the study to placebo or active medication, to determine if Diclofenac reduces the incidence of pancreatitis.
Condition | Intervention | Phase |
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Pancreatitis |
Drug: diclofenac Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients: A Prospective, Randomized, Double Blind, Placebo Controlled Trial. |
Estimated Enrollment: | 100 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
placebo suppository
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Drug: placebo
similar shape and size suppository
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2: Active Comparator
diclofenac suppository
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Drug: diclofenac
100 mg diclofenac rectal suppository
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Any of the following factors placing a patient at high risk (>10%) of post ERCP pancreatitis:
Exclusion Criteria:
Contact: Lawrence Hookey, MD | (613) 544-3400 ext 2288 | hookeyl@hdh.kari.net |
Contact: Brenda Delonghi | (613) 544-3400 ext 2288 | delonghb@hdh.kari.net |
Canada, Ontario | |
Kingston General Hospital | Recruiting |
Kingston, Ontario, Canada | |
Principal Investigator: Lawrence Hookey, MD |
Principal Investigator: | Lawrence Hookey, MD | Queen's University |
Responsible Party: | Queen's University ( Dr. Lawrence Hookey ) |
Study ID Numbers: | diclofenac trial hookey |
Study First Received: | January 25, 2007 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00428025 History of Changes |
Health Authority: | Canada: Health Canada |
pancreatitis |
Anti-Inflammatory Agents Digestive System Diseases Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Diclofenac Pancreatic Diseases |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Pancreatitis |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Diclofenac Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Pancreatic Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Pancreatitis |