Trial · NCT01912716

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

NCT01912716, Phase 2, Phase 3, Completed, Indiana University; results first posted 2019-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis. Trials, record NCT01912716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01912716

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
NCT number: NCT01912716
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,037 participants, actual
Lead sponsor: Indiana University
Conditions: Post-ERCP Pancreatitis
Interventions: high dose indomethacin, standard dose indomethacin
First posted: 2013-07-31
Last updated: 2019-07-05
Results first posted: 2019-06-18
Limitations and caveats: This study took place at 6 tertiary medical centers in the United States. However, approximately 3/4 of patients were enrolled from a single site.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Developed Post-ERCP Pancreatitis	5 days	Assessment of whether patients developed post-ERCP pancreatitis, defined as a new onset of pain (or worsening of existing pain) in the upper abdomen, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.
Secondary	Number of Participants With Moderate or Severe Post-ERCP Pancreatitis	30 days	Assessment of whether patients developed either moderate or severe post-ERCP pancreatitis, defined according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93). Severity of post-ERCP pancreatitis is partly defined according to length of stay. Moderate pancreatitis is defined as a 4-10 day hospitalization. Severe post-ERCP pancreatitis is defined as a hospitalization of greater than 10 days post-ERCP, or development of a complication (eg. pseudocyst or necrosis), or need for intervention (drainage or surgery).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Developed Post-ERCP Pancreatitis	5 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Moderate or Severe Post-ERCP Pancreatitis	30 days	development of moderate or severe post-ERCP pancreatitis	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants Who Developed Post-ERCP Pancreatitis	Standard 100mg Dose	76	Participants
Number of Participants Who Developed Post-ERCP Pancreatitis	High Dose 200 mg	65	Participants
Number of Participants With Moderate or Severe Post-ERCP Pancreatitis	Standard Dose 100 mg	28	Participants
Number of Participants With Moderate or Severe Post-ERCP Pancreatitis	High Dose 200mg	28	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High-dose Indomethacin	522
Overall Study	STARTED	Standard Dose Indomethacin	515
Overall Study	Receipt of 2nd Dose	High-dose Indomethacin	511
Overall Study	Receipt of 2nd Dose	Standard Dose Indomethacin	503
Overall Study	5-day Follow-up	High-dose Indomethacin	522
Overall Study	5-day Follow-up	Standard Dose Indomethacin	515
Overall Study	3-day Follow-up	High-dose Indomethacin	521
Overall Study	3-day Follow-up	Standard Dose Indomethacin	513
Overall Study	COMPLETED	High-dose Indomethacin	522
Overall Study	COMPLETED	Standard Dose Indomethacin	515

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	pancreatitis	Gastrointestinal disorders	Standard-dose Indomethacin	76	515	76
serious	pancreatitis	Gastrointestinal disorders	High-dose Indomethacin	65	522	65
serious	bleeding	Gastrointestinal disorders	Standard-dose Indomethacin	6	515	6
serious	bleeding	Gastrointestinal disorders	High-dose Indomethacin	8	522	8
serious	renal failure	Renal and urinary disorders	Standard-dose Indomethacin	0	515	0
serious	renal failure	Renal and urinary disorders	High-dose Indomethacin	3	522	3
serious	myocardial infarction	Cardiac disorders	Standard-dose Indomethacin	1	515	1
serious	myocardial infarction	Cardiac disorders	High-dose Indomethacin	0	522	0
serious	transient ischaemic attack	Nervous system disorders	Standard-dose Indomethacin	0	515	0
serious	transient ischaemic attack	Nervous system disorders	High-dose Indomethacin	1	522	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard-dose Indomethacin	0	515
Total, all-cause mortality	High-dose Indomethacin	0	522
Total, other adverse events	Standard-dose Indomethacin	0	0
Total, other adverse events	High-dose Indomethacin	0	0
Total, serious adverse events	Standard-dose Indomethacin	83	515
Total, serious adverse events	High-dose Indomethacin	77	522

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31780277	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Standard Dose 100 mg vs High Dose 200mg: Number of Participants With Moderate or Severe Post-ERCP Pancreatitis	Trial comparisons
Standard-dose Indomethacin vs High-dose Indomethacin: deaths from any cause	Trial comparisons
Standard 100mg Dose vs High Dose 200 mg: Number of Participants Who Developed Post-ERCP Pancreatitis	Trial comparisons
Standard-dose Indomethacin vs High-dose Indomethacin: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01912716

GET https://conductscience.org/api/trials/v1/NCT01912716/registered

API reference For AI assistants