AuthorisedTherapeutic use (Phase IV)Interventional

Ursodeoxycolic acid for the prevention of relapsing complications after gallstone acute pancreatitis, a double-blind multicenter randomized-controlled trial.

This research is looking into a medicine called Ursodeoxycholic acid, also known as URSOBILANE, to find out if it can help prevent repeat problems after someone has had a severe attack of pancreatitis caused by gallstones. Pancreatitis is when the pancreas becomes inflamed. The study is for adults aged 18 and over, and both men and women can take part. Participants will either receive the active medicine or a dummy pill (placebo) without knowing which one they are taking. Researchers will then observe if this medicine can reduce the chances of further complications such as new episodes of pancreatitis, infections (cholangitis, cholecystitis), or other gallstone-related issues, right up until they have surgery to remove their gallbladder or for up to one year. This is a "Phase IV" study, meaning the medicine is already approved for some uses, but researchers are now looking at a new way it might help.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital General Universitario Dr. Balmis

Enrolment target

332

Start

04 Dec 2024

recurrence of acute biliary pancreatitis

What is this study about?

Imagine you've had a very painful and serious inflammation of your pancreas, called pancreatitis, which was caused by gallstones. Gallstones are small, hardened deposits that can form in your gallbladder and sometimes cause blockages or irritation. After such an attack, there's a risk of having more problems from these gallstones.

This study is trying to find out if a medicine called Ursodeoxycholic acid, often shortened to UDCA or sold under the brand name URSOBILANE, can help prevent these problems from happening again. Participants will be given either this medicine or a 'dummy' pill that looks the same but contains no active medicine. Neither you nor your doctor will know which you are receiving, which helps ensure the results are fair and unbiased. The main goal is to see if URSOBILANE can reduce further serious issues like another attack of pancreatitis, infections, or pain caused by gallstones, before you have an operation to remove your gallbladder, or for a year if surgery is delayed.

This type of study is called a 'Phase IV' trial. This means the medicine (Ursodeoxycholic acid) is already approved and used for other health conditions. Researchers are now exploring a new possible benefit for people who have had gallstone-related pancreatitis. By carefully studying how well this medicine works and if it prevents future problems, doctors can learn how to better care for patients like you in the future.

Key takeaways

Tests if URSOBILANE medicine can prevent health problems from gallstones after pancreatitis.
Compares URSOBILANE to a dummy pill in adults (18+).
Aims to reduce new problems like more pancreatitis attacks before gallbladder surgery.
Involves regular health checks and reporting any new symptoms.
Medicine is already approved for other uses (Phase IV study).

Who may be eligible?

This study is looking for adults who have recently experienced a painful attack of pancreatitis that was caused by gallstones. You must be 18 years old or older to take part; there is no upper age limit.

Both men and women are welcome to participate in this research. The most important thing is that your pancreatitis was definitely linked to gallstones and that you are otherwise suitable for the study after a doctor has reviewed your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have you had acute pancreatitis caused by gallstones?
Are you 18 years old or older?
Are you waiting for surgery to remove your gallbladder?
Are you able to attend regular appointments and take daily medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the study medicine (URSOBILANE) or an inactive dummy pill. You will take this medicine every day as directed by the study team. You will have regular appointments with the study doctors and nurses, who will monitor your health closely and ask you about any new symptoms you might experience. These visits will involve health checks and possibly blood tests.

The study will continue until you have an operation to remove your gallbladder or for up to one year, whichever comes first. This means the total length of your participation could vary. You will also be asked to report any new gallstone-related complications, such as another pancreatitis attack or pain, during this time.

Potential risks and benefits

Participating in this study might offer you the potential benefit of reducing further gallstone-related complications before your gallbladder surgery or over the next year. You will also receive careful monitoring of your health by the study team. As with all medicines, Ursodeoxycholic acid can have side effects, though it is generally well-tolerated. Potential risks might include experiencing side effects from the medication or the possibility that the study medicine might not prevent future problems. There's also the chance you might receive the dummy pill, which won't offer a direct medical benefit. You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What are gallstones?

Gallstones are small, hard lumps that can form in your gallbladder, a small organ that helps with digestion. They don't always cause problems, but sometimes they can block bile ducts or irritate the pancreas, leading to pain and serious health issues.

What is pancreatitis?

Pancreatitis is inflammation of the pancreas, a gland behind your stomach. When inflamed, it can cause severe belly pain and other complications. Gallstones are a common cause of pancreatitis.

What does 'double-blind' mean?

In a 'double-blind' study, neither you nor your doctor will know whether you are receiving the active medicine or the dummy pill. This helps ensure that the study results are as fair and unbiased as possible.

What is a 'dummy pill' or 'placebo'?

A dummy pill, or placebo, looks exactly like the study medicine but doesn't contain any active drug. It's used in studies to compare the effects of the active medicine against no treatment, so researchers can clearly see if the medicine is truly working.

How long will I be in the study?

You'll be in the study until you have surgery to remove your gallbladder or for up to one year, whichever happens first. The exact length will depend on your individual treatment plan.