Trial Outcomes & Findings for Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients (NCT NCT00820612)

NCT ID: NCT00820612

Last Updated: 2013-02-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

602 participants

Primary outcome timeframe

5 days

Results posted on

2013-02-28

Participant Flow

Between February 2009 and July 2011, 602 subjects were enrolled at 4 university-affiliated medical centers in the United States.

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.

Participant milestones

Participant milestones
Measure	Placebo 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.	Indomethacin 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
Overall Study STARTED	307	295
Overall Study COMPLETED	307	295
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=307 Participants 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.	Indomethacin n=295 Participants 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.	Total n=602 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	280 Participants n=5 Participants	272 Participants n=7 Participants	552 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Age Continuous	46.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	44.5 years STANDARD_DEVIATION 13.5 • n=7 Participants	45.3 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	247 Participants n=5 Participants	229 Participants n=7 Participants	476 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	66 Participants n=7 Participants	126 Participants n=5 Participants
Region of Enrollment United States	307 participants n=5 Participants	295 participants n=7 Participants	602 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: 100% completed follow-up

Outcome measures

Outcome measures
Measure	Placebo n=307 Participants 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.	Indomethacin n=295 Participants 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
Post-ERCP Pancreatitis	52 participants 37.6	27 participants 28.9

Adverse Events

Placebo

Serious events: 61 serious events

Other events: 0 other events

Deaths: 0 deaths

Indomethacin

Serious events: 31 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=307 participants at risk 2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.	Indomethacin n=295 participants at risk 2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
Gastrointestinal disorders GI bleeding	2.3% 7/307 • Number of events 7 • 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.	1.4% 4/295 • Number of events 4 • 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.
Renal and urinary disorders Renal failure	0.65% 2/307 • Number of events 2 • 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.	0.00% 0/295 • 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.
Gastrointestinal disorders Post-ercp pancreatitis	16.9% 52/307 • Number of events 52 • 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.	9.2% 27/295 • Number of events 27 • 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.

Other adverse events

Adverse event data not reported

Additional Information

B. Joseph Elmunzer, MD.

University of Michigan

Phone: 735 615 6652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place