Phase 3 Pancreatitis Trial, Recruiting NCT04924868 Sponsor: Hospital General Universitario de Alicante Condition: Pancreatitis
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Phase 3 Pancreatitis Trial, Recruiting

NCT04924868
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been admitted to hospital with acute pancreatitis, meaning you have at least 2 of these: typical pancreatitis pain, blood enzyme levels (amylase and/or lipase) more than 3 times the normal limit, or a scan showing signs of acute pancreatitis
  • You have gallstones that have been detected by any type of scan or imaging
  • You are willing and able to give your informed consent to take part

Who may not be able to join:

  • You have already had your gallbladder removed, or have had certain procedures to examine or treat your bile ducts (called ERCP or endoscopic cholecystostomy)
  • You have had one or more previous episodes of pancreatitis of any kind
  • You are already on a waiting list at the same hospital to have your gallbladder removed, and that wait is less than 30 days
  • You are being enrolled more than 3 days after being discharged from hospital for your pancreatitis
  • You have taken a medication called ursodeoxycholic acid (UDCA) in the last 5 years, or it has been tried before and did not dissolve your gallstones
  • You are allergic to, cannot tolerate, or have a medical reason not to take UDCA — for example, an active stomach or intestinal ulcer, certain liver or gut conditions, or you are breastfeeding (confirm with trial site)
  • You have stones in your bile duct (not just the gallbladder), detected by a scan before joining the trial
  • You drink heavily — 5 or more alcoholic drinks per day if you are a man, or 3 or more if you are a woman — or there is a strong suspicion of a significant alcohol problem
  • You have a recent history of not following medical treatment as directed, or have personal circumstances that would make it hard to attend follow-up appointments
  • Your blood triglyceride (fat) levels are above 400 mg/dL during your hospital stay, or you have a history of severely high triglycerides that are difficult to control
  • You have chronic (long-term) pancreatitis, shown by calcium deposits in the pancreas or a widened pancreatic duct of 4mm or more
  • You have cysts on your pancreas that are not related to your current pancreatitis episode
  • You have a narrowing of the main pancreatic duct (confirm with trial site)
  • You have a condition called primary hyperparathyroidism (a problem with one of the glands in your neck that affects calcium levels)
  • You are pregnant

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Enrique De Madaria, Medicine, Alicante General University Hospital

Phone: (+34) 661302932

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Hospital General Universitario de Alicante
Registry
ClinicalTrials.gov
Start date
10 November 2021
Est. completion
1 July 2027

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Complication due to gallstones

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov