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Stopped by DSMB for overwhelming benefit of indomethacin (unethical to withhold indomethacin from patients)
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| University of Kentucky | OTHER |
| Case Western Reserve University | OTHER |
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Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Indomethacin suppository |
|
| 2 | Placebo Comparator | Placebo suppository |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | 100 mg PR once at the time of ERCP |
| |
| Placebo suppositories |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Pancreatitis | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights. | 5 days |
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Inclusion Criteria:
Included patients are those undergoing ERCP and have one of the following:
or at least 2 of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Badih J Elmunzer, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States | ||
| University of Kentucky |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22494121 | Derived | Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103. |
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Of the 799 consented subjects, 169 were not randomized because an inclusion criterion was not met, 11 were not randomized because an exclusion criterion was met, and 17 were not randomized because ERCP not performed.
Between February 2009 and July 2011, 602 subjects were enrolled at 4 university-affiliated medical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. |
| FG001 | Indomethacin | 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
2 placebo suppositories at the time of ERCP |
|
| Lexington |
| Kentucky |
| 40536 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. |
| BG001 | Indomethacin | 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights. | 100% completed follow-up | Posted | Number | participants | 5 days |
|
|
|
30 days
All reported adverse events were events potentially related to the study medication. The other major adverse event was post-ERCP pancreatitis, which was reported as the primary outcome, but would not be related to the treatment. All patients were systematically followed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. | 61 | 307 | 0 | 307 | ||
| EG001 | Indomethacin | 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room. | 31 | 295 | 0 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Post-ercp pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| B. Joseph Elmunzer, MD. | University of Michigan | 735 615 6652 | badihe@umich.edu |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|