NCT01774604

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 20, 2016

Completed
Last Updated

November 4, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

January 21, 2013

Results QC Date

July 29, 2016

Last Update Submit

September 28, 2016

Conditions

Post-ERCP Acute Pancreatitis

Keywords

Post ERCP acute pancreatitisPost Fine Needle Aspiration (FNA) acute pancreatitisIndomethacinRectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Developed Acute Pancreatitis

    Number of patients who developed pancreatitis following ERCP based on Atlanta Classification

    From randomization to 30 days after ERCP

Secondary Outcomes (6)

  • Number of Patients Who Developed Severe Pancreatitis

    From randomization to 30 days after ERCP

  • Number of Patients Who Developed Moderately Severe Pancreatitis

    From randomization to 30 days after ERCP

  • Number of Patients Who Developed Mild Pancreatitis

    From randomization to 30 days after ERCP

  • Number of Patients Who Developed Gastrointestinal Bleeding

    From randomization to 30 days after ERCP

  • Number of Patient Deaths

    From randomization to 30 days after ERCP

  • +1 more secondary outcomes

Study Arms (2)

Indomethacin

EXPERIMENTAL

Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period

Drug: Indomethacin

Placebo

PLACEBO COMPARATOR

Placebo suppositories (#2)

Drug: Placebo

Interventions

IndomethacinDRUG

100 mg Indomethacin PR x 1

Indomethacin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for an ERCP at Dartmouth-Hitchcock
  • Age greater than 18 years old
  • Ability to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • 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.

    PMID: 26775631BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

The study was terminated due to indomethacin's lack of efficacy after 449 patients had been enrolled. Thus the study may be underpowered to draw conclusions about the role of indomethacin in preventing post ERCP pancreatitis

Results Point of Contact

Title
John M. Levenick
Organization
Penn State Hershey Medical Center/Dartmouth-Hitchcock Medical Center
jlevenick@hmc.psu.edu
603-667-1332

Study Officials

  • John M Levenick, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 4, 2016

Results First Posted

September 20, 2016

Record last verified: 2016-09

Locations

US(1)