Trial Outcomes & Findings for A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis (NCT NCT00736073)

NCT ID: NCT00736073

Last Updated: 2015-06-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2015-06-22

Participant Flow

Subjects scheduled for ERCP as outpatient procedure in Duke clinic between Aug 2007 and October 2009

Investigational product to be given 4 hours before procedure

Participant milestones

Measure	Arm 1-medication Pre and Post Procedure Aprepitant aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Arm 2-Randomized to Placebo Placebo Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Overall Study STARTED	34	39
Overall Study COMPLETED	34	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Baseline characteristics by cohort

Measure	Arm 1-medication Pre and Post Procedure n=34 Participants aprepitant aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Arm 2-Randomized to Placebo n=39 Participants Placebo Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Total n=73 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	34 Participants n=5 Participants	39 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 17 • n=5 Participants	46 years STANDARD_DEVIATION 12 • n=7 Participants	48 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	39 participants n=7 Participants	73 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: The number of participants who received the aprepitant or placebo were evaluated for ERCP pancreatitis. Each case of ERCP pancreatitis was tracked for the participant.

Outcome measures

Measure	Arm 1-medication Pre and Post Procedure n=34 Participants aprepitant aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Arm 2-Randomized to Placebo n=39 Participants Placebo Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Number of Post-ERCP Pancreatitis Cases in Participants Who Are Administered Aprepitant and Placebo Prior to ERCP and One Day After ERCP:Assess the Total Number of Incidents of Post-ERCP Pancreatitis in Each Group (Treatment and Control).	7 cases of ERCP in participants Interval 1.0 to 73.0	7 cases of ERCP in participants Interval 1.0 to 73.0

SECONDARY outcome

Timeframe: 48 hours post ERCP and 1 week post ERCP

Population: There are 2 telephone assessments that participants are required to complete in order to analyze the outcome measure. The study team was unable to collect both assessments within the required timeframe due missed calls \& lack of return calls from participants. Therefore data collection and analysis could not be completed per protocol.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Measure	Arm 1-medication Pre and Post Procedure n=34 Participants aprepitant aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Arm 2-Randomized to Placebo n=39 Participants Placebo Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis	6 participants	9 participants

Adverse Events

Arm 1-medication Pre and Post Procedure

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2-Randomized to Placebo

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1-medication Pre and Post Procedure n=34 participants at risk aprepitant aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose	Arm 2-Randomized to Placebo n=39 participants at risk Placebo Placebo : one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Endocrine disorders ERCP pancreatitis	20.6% 7/34 • Number of events 7	17.9% 7/39 • Number of events 7

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martin Poleski

DUMC

Phone: 9196841817

Email: martin.poleski@dm.duke.edu

Results disclosure agreements

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