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Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria

• Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening

• Within 6 weeks of onset of disease

• Able to take food orally

• Age 18-60 years

• Both genders

Locations
Other Locations
India
Gauhati Medical College
RECRUITING
Guwahati
Asian Institute of Gastroenterology Hospitals, Gachibowli
RECRUITING
Hyderabad
Asian Institute of Gastroenterology, Banjara Hills
RECRUITING
Hyderabad
ILS Hospital, Dum Dum
RECRUITING
Kolkata
Contact Information
Primary
Abdul Rasheed, PharmD
abdulrasheedmd1223@gmail.com
+919652104726
Time Frame
Start Date: 2026-04-10
Estimated Completion Date: 2027-06
Participants
Target number of participants: 140
Treatments
Experimental: Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m
Placebo_comparator: Similar appearing glucose capsules will be provided three times a day along with food
Drug: Placebo Similar appearing glucose capsules
Sponsors
Leads: Asian Institute of Gastroenterology, India

This content was sourced from clinicaltrials.gov