Trial Outcomes & Findings for IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis (NCT NCT02241512)

NCT ID: NCT02241512

Last Updated: 2020-02-18

Results Overview

Number of patients who develop post-ERCP pancreatitis

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-02-18

Participant Flow

10 patients excluded after enrollment. 5 did not undergo ERCP and thus did not receive a study drug. 3 did not have study drug available in time for procedure. 2 did not meet inclusion criteria.

Participant milestones

Measure	Ibuprofen Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo Single dose IV normal saline placebo
Overall Study STARTED	30	29
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Ibuprofen Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo Single dose IV normal saline placebo
Overall Study Pump malfunction, drug not delivered	1	0

Baseline Characteristics

IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis

Baseline characteristics by cohort

Measure	Ibuprofen n=29 Participants Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 Participants Single dose IV normal saline placebo	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	29 Participants n=93 Participants	29 Participants n=4 Participants	58 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	20 Participants n=93 Participants	21 Participants n=4 Participants	41 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Mean Pain Score	2.9 units on a Likert scale n=93 Participants	2.2 units on a Likert scale n=4 Participants	2.6 units on a Likert scale n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of patients who develop post-ERCP pancreatitis

Outcome measures

Measure	Ibuprofen n=29 Participants Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 Participants Single dose IV normal saline placebo
Post-ERCP Pancreatitis	2 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 weeks

Number of patients who develop post-ERCP bleeding

Outcome measures

Measure	Ibuprofen n=29 Participants Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 Participants Single dose IV normal saline placebo
Post-ERCP Bleeding	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-procedural, 24 hours

Number of patients with increased pain scores after the procedure

Outcome measures

Measure	Ibuprofen n=29 Participants Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 Participants Single dose IV normal saline placebo
Increased Pain Score	1 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-procedural, 24 hours

Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)

Outcome measures

Measure	Ibuprofen n=29 Participants Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 Participants Single dose IV normal saline placebo
24-h Post-ERCP Pain Score	1.1 score on a Likert pain scale Interval 0.0 to 2.0	3.1 score on a Likert pain scale Interval 0.0 to 6.0

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ibuprofen n=29 participants at risk Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen	Placebo n=29 participants at risk Single dose IV normal saline placebo
Gastrointestinal disorders Pancreatitis	6.9% 2/29 • Number of events 2 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.	17.2% 5/29 • Number of events 5 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/29 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.	10.3% 3/29 • Number of events 3 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.
Gastrointestinal disorders Bleeding	6.9% 2/29 • Number of events 2 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.	0.00% 0/29 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.
Hepatobiliary disorders Cholangitis	0.00% 0/29 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.	3.4% 1/29 • Number of events 1 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.
Gastrointestinal disorders Perforation	3.4% 1/29 • Number of events 1 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.	0.00% 0/29 • 2 weeks All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.

Additional Information

Dr. David Troendle

UT Southwestern

Phone: 214456-8000

Email: david.troendle@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place