Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis
CompletedNot applicableNCT05042284
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Effect of Non-enteric Coated Enzymes Substitution on Pain in Patients With Chronic Pancreatitis: a Double -Blinded Placebo Controlled Randomized Trial (NE-PERT Trial)
- Conditions
- Interventions
- Drug: Non-enteric coated pancreatic enzyme preparation
- Sponsor
- Asian Institute of Gastroenterology, India
- Start date
- 2021-09-01
- Primary completion
- 2024-07-30
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- India
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05042284