Post-ERCP Acute PancreatitisPhase 3NCT01774604
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
A Phase 3 study testing Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- Indomethacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for an ERCP at Dartmouth-Hitchcock
- Age greater than 18 years old
- Ability to provide written informed consent
Who cannot join
- Inability to provide written informed consent
- ERCP being performed for diagnosis and/or treatment of acute pancreatitis
- Current ongoing acute pancreatitis
- Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
- Pregnant or nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Indomethacin, Placebo
- Keywords
- Post ERCP acute pancreatitis, Post Fine Needle Aspiration (FNA) acute pancreatitis, Indomethacin, Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndomethacinDrug
100 mg Indomethacin PR x 1
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin | Experimental | Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period Receives: Drug: Indomethacin |
| Placebo | Placebo comparator | Placebo suppositories (#2) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Developed Acute Pancreatitis
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Measured: From randomization to 30 days after ERCP
Secondary outcomes (6)
Number of Patients Who Developed Severe Pancreatitis
Number of patients with severe acute pancreatitis based on the Atlanta Classification
Measured: From randomization to 30 days after ERCP
Number of Patients Who Developed Moderately Severe Pancreatitis
Number of patients with moderately severe pancreatitis based on Atlanta Classification
Measured: From randomization to 30 days after ERCP
Number of Patients Who Developed Mild Pancreatitis
Number of patient who developed mild acute pancreatitis based on the Atlanta Classification
Measured: From randomization to 30 days after ERCP
Number of Patients Who Developed Gastrointestinal Bleeding
Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
Measured: From randomization to 30 days after ERCP
Number of Patient Deaths
Number of patients who died from any cause from the time of ERCP until 30 days post-procedure
Measured: From randomization to 30 days after ERCP
Number of Patients With 30 Days Hospital Re-admission
Number of patients admitted to the hospital for any cause following ERCP
Measured: From randomization until 30 days after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Futility
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M Levenick, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774604
- Sponsor's protocol ID
- CPHS#23749
- Status last verified
- Sep 2016
- First submitted
- 21 Jan 2013
- Last updated
- 4 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.
PubMed 26775631
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT01774604
- Acronym / sponsor ID
- CPHS#23749
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- Post ERCP acute pancreatitis, Post Fine Needle Aspiration (FNA) acute pancreatitis, Indomethacin, Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 20 Sep 2016
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 assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | Experimental | Drug: IndomethacinIndomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo suppositories (#2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled for an ERCP at Dartmouth-Hitchcock
- Age greater than 18 years old
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Inability to provide written informed consent
- ERCP being performed for diagnosis and/or treatment of acute pancreatitis
- Current ongoing acute pancreatitis
- Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
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 |
|---|---|---|
| Indomethacin100 mg Indomethacin PR x 1 | Drug | Indomethacin |
| Placebo | Drug | Placebo |
Primary outcome
Number of Patients Who Developed Acute Pancreatitis
Time frame: From randomization to 30 days after ERCP
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
6 secondary outcomes
Number of Patients Who Developed Severe Pancreatitis
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Moderately Severe Pancreatitis
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Mild Pancreatitis
Time frame: From randomization to 30 days after ERCP
Number of Patients Who Developed Gastrointestinal Bleeding
Time frame: From randomization to 30 days after ERCP
Number of Patient Deaths
Time frame: From randomization to 30 days after ERCP
Number of Patients With 30 Days Hospital Re-admission
Time frame: From randomization until 30 days after ERCP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26775631Levenick JM, Gordon SR, Fadden LL, Levy LC, Rockacy MJ, Hyder SM, Lacy BE, Bensen SP, Parr DD, Gardner TB. Rectal Indomethacin Does Not Prevent Post-ERCP Pancreatitis in Consecutive Patients. Gastroenterology. 2016 Apr;150(4):911-7; quiz e19. doi: 10.1053/j.gastro.2015.12.040. Epub 2016 Jan 9.
Related trials for Post-ERCP Acute Pancreatitis
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
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An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
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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.
John M Levenick, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Nov 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2016). 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 Patients Who Developed Acute Pancreatitis (time frame: From randomization to 30 days after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01774604, which also lists 1 linked publication.
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 4 Nov 2016.