Trial Outcomes & Findings for A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis (NCT NCT00727740)

Results Overview

Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

117 participants

Primary outcome timeframe

24 hours

Results posted on

2017-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	1- Indomethacin Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline. Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.	2- Placebo Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline. Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.
Overall Study STARTED	56	61
Overall Study COMPLETED	56	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1- Indomethacin n=56 Participants Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline. Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.	2- Placebo n=61 Participants Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline. Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.	Total n=117 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 18.3 • n=5 Participants	56.6 years STANDARD_DEVIATION 13.5 • n=7 Participants	55.4 years STANDARD_DEVIATION 16.1 • n=5 Participants
Gender Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Gender Male	34 Participants n=5 Participants	37 Participants n=7 Participants	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Pancreatitis was operationally defined as post-ERCP pancreatitis (PEP). PEP was defined as abdominal pain with elevated serum amylase level (3 times above the upper limit of normal). The change in Pancreatitis rate calculated as the percentage of participants with pancreatitis at baseline minus percentage of participants with pancreatitis at 24 hours.

Outcome measures

Outcome measures
Measure	1- Indomethacin n=56 Participants Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline. Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.	2- Placebo n=61 Participants Placebo suspension in the same volume (20 cc) which is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. The placebo suspension is also flushed with 5 cc of normal saline. Placebo suspension: A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.
Reduction in Pancreatitis Rate	16.1 percentage of participants with PEP	4.9 percentage of participants with PEP

Adverse Events

1- Indomethacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2- Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Priya Jamidar, MD

Yale University School of Medicine

Phone: 203-785-6228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place