Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

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Dartmouth Health

Status and phase

Terminated
Phase 3

Conditions

Post-ERCP Acute Pancreatitis

Treatments

Drug: Indomethacin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01774604
CPHS#23749

Details and patient eligibility

About

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.

Enrollment

449 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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 design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

449 participants in 2 patient groups, including a placebo group

Indomethacin
Experimental group
Description:
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
Treatment:
Drug: Indomethacin
Placebo
Placebo Comparator group
Description:
Placebo suppositories (#2)
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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