PancreatitisNCT00736073
A Trial of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
A study testing aprepitant in people with Pancreatitis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- aprepitant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- active pancreatitis
- if they are pregnant
- known adverse reaction to aprepitant
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.
Read the detailed description
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.
Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.
- Conditions
- Pancreatitis
- Being tested
- aprepitant, Placebo
- Keywords
- pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | aprepitant Receives: Drug: aprepitant |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours
Secondary outcomes (2)
Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis
Measured: 48 hours post ERCP and 1 week post ERCP
Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Martin Poleski, MD, Principal investigator, Duke University Medical Center, Department of Medicine, Division of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736073
- Sponsor's protocol ID
- Pro00005149
- Status last verified
- Apr 2015
- First submitted
- 13 Aug 2008
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Prospective Trial of Oral Administration of Aprepitant For Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
- ClinicalTrials.gov ID
- NCT00736073
- Acronym / sponsor ID
- Pro00005149
- Conditions
- Pancreatitis
- Keywords
- pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 19 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.
Detailed description
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.
Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: aprepitantaprepitant |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- active pancreatitis
- if they are pregnant
- known adverse reaction to aprepitant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aprepitantone dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose | Drug | 1 |
| Placeboone dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose | Drug | 2 |
Primary outcome
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).
Time frame: 48 hours
2 secondary outcomes
Incidence of Pain Post-ERCP, Within 48 Hours of ERCP, and at 1 Week Post-ERCP; Unrelated to Pancreatitis
Time frame: 48 hours post ERCP and 1 week post ERCP
Number of Participants Who Were Hospitalized Within 7 Days Post-ERCP for Abdominal Pain That Did Not Meet Criteria for Acute Pancreatitis
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Poleski, MD principal investigator
Duke University Medical Center, Department of Medicine, Division of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aprepitant in people with Pancreatitis, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.