Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis

NCT05042284 | Completed DMC

• 1 other identifier: NE PERT 1
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Pain in CP entails several independent yet overlapping mechanisms including oxidative stress-mediated parenchymal inflammation, pancreatic and central neuropathy and neuroplasticity. Medical modalities for long-term pain management includes antioxidants and neuromodulators. Pancreatic enzymes are also invariably used for pain management. CP with ductal obstruction and pain is treated with either endotherapy or drainage surgery. However, it has been observed that a substantially increasing proportion of patients experience pain recurrence as the duration of follow-up after endotherapy or surgery gets longer. Neural and dietary (proteins) stimuli activate CCK receptors in D1 \& D2 which gives a positive feedback signal for pancreatic secretion. Once enzyme secretion starts, due to ductal and interstitial/tissue hypertension, nociception begins that results in pain. Blockade of the duodenal CCK receptors could inhibit the positive feedback loop, thereby reducing pancreatic secretion and resulting pain. Currently available enteric coated enzyme supplements are released throughout the small bowel and therefore may not be released sufficiently in the duodenum to effectively suppress the feedback loops. High doses of proteases (\~25k-30k) would be required to block the receptors, while most of the currently available preparations have higher lipase but not proteases. This led to the investigators' hypothesis that negative feedback of CCK by non enteric coated pancreatic enzymes could ameliorate pain in a more effective manner by NE-PERT.

Conditions

Chronic Pancreatitis; Pain

Outcome Measures

Primary Outcomes (2)

• Change in pain score 1

  Visual analogue score will be used. Score ranges from 0-10, 10 indicating most severe.

  3 months

• Change in pain score 2

  Izbicki pain score will be used. Score ranges from 0-100, 100 indicating most severe.

  3 months

Secondary Outcomes (10)

• Change in pain score 1

  6 months

• Change in pain score 2

  6 months

• Change in number of painful days

  3 months

• Change in number of painful days

  6 months

• Change in quality of life

  3 months

Other Outcomes (6)

• Change in Quantitative sensory testing parameters (pin prick) [First follow-up]

  3 months

• Change in Quantitative sensory testing parameters (pin prick) [Second follow-up]

  6 months

• Change in Quantitative sensory testing parameters (cold tolerance) [First follow-up]

  3 months

Study Arms (2)

NE PERT

EXPERIMENTAL

Non-enteric coated pancreatic enzyme capsules containing 30,000U of protease will be provided three times a day along with food (breakfast, lunch and dinner)

Drug: Non-enteric coated pancreatic enzyme preparation

Placebo

PLACEBO COMPARATOR

Similar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner)

Drug: Non-enteric coated pancreatic enzyme preparation

Interventions

Non-enteric coated pancreatic enzyme preparation DRUG

The patients will be given a non-enteric coated pancreatic enzyme capsule containing 30000 U of protease thrice daily along with meals for 3 months.

Also known as: Placebo

NE PERT; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic pancreatitis of at least 3 years
• At least 3 episodes of pain in the past 3 months
• Pain score of at least 3 on VAS (0-10)
• Age 18-60yrs
• Both genders

You may not qualify if:

• Acute pancreatitis episode at the time of enrolment.
• Pancreatic cancer.
• Other chronic painful conditions.
• Active substance use (alcohol, smoking, smokeless tobacco, illicit drugs).
• Pregnancy and lactation.
• Inability to give informed consent.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pain

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rupjyoti Talukdar, MD, AGAF

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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; Head, Pancreas Research Group and Division of Gut Microbiome Research

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 13, 2021
• Study Start: September 1, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 6 months of data publication, on reasonable request.

Locations

IN (1)