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New treatment option for Acute Necrotizing Pancreatitis
Official title Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
ClinicalTrials.gov ID: NCT07441824
What this study is testing
What is Pancreatic enzyme capsules?
Pancreatic enzyme capsules is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute necrotizing pancreatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join 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...
- Within 6 weeks of onset of disease
- Able to take food orally
- Age 18-60 years
You likely can't join if
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
- Inability to give informed consent.
See the full eligibility criteria
- 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
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
- Inability to give informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Guwahati, Assam, India
- Hyderabad, Telangana, India
- Kolkata, West Bengal, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guwahati, Assam, India; Hyderabad, Telangana, India; Kolkata, West Bengal, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.