Actively Recruiting

Phase 3
Age: 18Years - 60Years
All Genders
NCT07441824

Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

Led by Asian Institute of Gastroenterology, India · Updated on 2026-05-05

140

Participants Needed

4

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and at least 5% loss of body weight. The primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.

CONDITIONS

Official Title

Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with acute pancreatitis according to the Revised Atlanta Classification
  • Acute pancreatitis episode with over 50% pancreatic tissue necrosis and at least 5% body weight loss
  • Within 6 weeks of disease onset
  • Able to eat food by mouth
  • Aged between 18 and 60 years
  • Both male and female participants
Not Eligible

You will not qualify if you...

  • Chronic pancreatitis
  • Recurrent acute pancreatitis
  • Pancreatic cancer
  • Patients discharged with nasojejunal (NJ) tubes
  • Pregnancy or breastfeeding
  • Unable to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Gauhati Medical College

Guwahati, Assam, India, 781032

Actively Recruiting

2

Asian Institute of Gastroenterology Hospitals, Gachibowli

Hyderabad, Telangana, India, 500032

Actively Recruiting

3

Asian Institute of Gastroenterology, Banjara Hills

Hyderabad, Telangana, India, 500082

Actively Recruiting

4

ILS Hospital, Dum Dum

Kolkata, West Bengal, India, 700080

Actively Recruiting

Loading map...

Research Team

A

Abdul Rasheed, PharmD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here