Comparison of effect of three methods of Rectal Naproxen Suppository, Isosorbide Dinitrate tablets and concurrent use of Rectal Naproxen Suppository with Isosorbide Dinitrate tablets in Prevention of Post- Endoscopic Retrograde Cholangio Pancreatography (ERCP) pancreatitis in patients

Effect of three methods of Naproxen ,Isosorbide Dinitrate and concurrent use of them in prevention of Post- ERCP Pancreatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201409251155N22

Enrollment

585

Registered

2015-10-14

Start date

2015-06-07

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post ERCP Pancreatitis. Other Acute Pancreatitis

Interventions

Intervention 1: Intervention group 1: Rectal Naproxen Suppository, 500 milligram, once immediately before ERCP, Manufacturing factory is Behvazan. Intervention 2: Intervention group 2: Isosorbide Din

Prevention

Treatment - Drugs

Intervention group 1: Rectal Naproxen Suppository, 500 milligram, once immediately before ERCP, Manufacturing factory is Behvazan

Intervention group 2: Isosorbide Dinitrate tablets, 5 milligram, once immediately before ERCP,Manufacturing factory is UCB Pharma GmbH

Intervention group 3: Concurrent use of naproxen suppository 500 milligram and Isosorbide Dinitrate tablets 5 milligram once immediately before ERCP

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: All patients over 18 years who were referred to Razi Hospital of Rasht for ERCP. Exclusion criteria: Acute pancreatitis in the last two weeks; history of chronic pancreatitis; a history of previous sphincterotomy; NSAID or Nitrate usage in a week prior and contraindication for NSAID or Nitrate usage like renal failure; recent Peptic Ulcer disease with recent GI Bleeding; Hypotension and Hypersensitivity to recent Each of the two drugs and lack of satisfaction of participate in this study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum levels of Amylase. Timepoint: Two hours after ERCP. Method of measurement: Laboratory Kit.;Symptoms of nausea, vomiting and abdominal pain. Timepoint: 2 hours after ERCP. Method of measurement: Observations with check list.	—

Secondary

Measure	Time frame
Serum levels of Amylase. Timepoint: 24 hours after ERCP. Method of measurement: Laboratory Kit.;Symptoms of nausea, vomiting and abdominal pain. Timepoint: 24 hours after ERCP. Method of measurement: Observation with check list.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Joukar

Gastrointestinal and Liver Disease Research Center(GLDRC)

F_Jokar@gums.ac.ir+98 13 3353 5116

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026