NCT07441824

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P25-P50 for phase_3

Timeline
10mo left

Started Apr 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
recruiting

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 Progress28%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

February 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 15, 2026

Last Update Submit

April 29, 2026

Conditions

Acute Necrotizing PancreatitisPancreatic Exocrine Insufficiency

Keywords

acute pancreatitispancrearic exocrine insufficiencypancreatic enzyme replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Percent change in body weight

    Body weight (in kg) will be measured at baseline and again at 3 months follow-up, and the difference between the two time points will be used to assess the effect of the intervention on patients' weight status. The change will be expressed as percent change of weight 3 months compared to baseline weight.

    3 months

Secondary Outcomes (16)

  • Change in quality of life

    3 months

  • Change in pancreatic exocrine function

    3 months

  • Change in nutritional status: Subjective Global Assesment (SGA)

    3 months

  • Change in nuritional status: Anthropometry

    3 months

  • Change in nutritional change: Anthropometry

    3 months

  • +11 more secondary outcomes

Other Outcomes (5)

  • Change in body composition (Bioimpedence analysis): Body fat mass (kg)

    3 months

  • Change in body composition (Bioimpedence analysis): Skeletal muscle mass (kg)

    3 months

  • Change in body composition (Bioimpedence analysis): Total body water (litres)

    3 months

  • +2 more other outcomes

Study Arms (2)

Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m

EXPERIMENTAL
Drug: Pancreatic enzyme capsules

Similar appearing glucose capsules will be provided three times a day along with food

PLACEBO COMPARATOR

Drug: Placebo Similar appearing glucose capsules

Drug: Placebo

Interventions

Pancreatic enzyme capsulesDRUG

Enteric coated pancreatic enzyme

Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m
PlaceboDRUG

Similar appearing glucose capsules

Similar appearing glucose capsules will be provided three times a day along with food

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Underlying chronic pancreatitis
  • Recurrent acute pancreatitis
  • Pancreatic cancer
  • Patients being discharged with NJ tubes
  • Pregnancy and lactation
  • Inability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Gauhati Medical College

Guwahati, Assam, 781032, India

RECRUITING

Asian Institute of Gastroenterology Hospitals, Gachibowli

Hyderabad, Telangana, 500032, India

RECRUITING

Asian Institute of Gastroenterology, Banjara Hills

Hyderabad, Telangana, 500082, India

RECRUITING

ILS Hospital, Dum Dum

Kolkata, West Bengal, 700080, India

RECRUITING

Related Publications (5)

  • Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.

    BACKGROUND

  • Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

    BACKGROUND

  • Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.

    BACKGROUND

  • Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.

    BACKGROUND

  • Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.

    BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute NecrotizingExocrine Pancreatic InsufficiencyPancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Rupjyoti Talukdar, MD

    Asian Institute of Gastroenterology Hospitals

    STUDY DIRECTOR

Central Study Contacts

Abdul Rasheed, PharmD

CONTACT

+919652104726abdulrasheedmd1223@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Pancreatology, AIG Hospitals

Study Record Dates

First Submitted

February 15, 2026

First Posted

March 2, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

IN(4)