Double-blind, randomised, placebo-controlled, phase IIa trial on the efficacy and tolerability of an 8-week treatment with two different doses of budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection
This research study is investigating a new medication called budesonide, given as a dissolving tablet. The main goal is to find out if this medicine can prevent a problem called oesophageal strictures. These are a narrowing of the food pipe that can sometimes happen after a stomach procedure known as endoscopic submucosal dissection. We are comparing two different doses of budesonide with a placebo, which is a tablet that looks the same but contains no active medicine. Participants will take the medicine for 8 weeks, and we'll be checking to see how many people haven't developed these strictures by the end of that period. This is an early-stage study to learn more about the medicine's effects.
At a glance
What is this study about?
This study is looking into a new way to prevent a problem that can sometimes happen after a specific stomach procedure called an endoscopic submucosal dissection. This procedure is used to remove growths or early cancers from the lining of the food pipe (oesophagus). Sometimes, after this, the food pipe can narrow, which is called an oesophageal stricture. This can make it difficult to swallow and might need further treatments to open it up.
We are testing a medicine called budesonide, which comes as a tablet that dissolves in your mouth. We want to see if taking this medicine after the stomach procedure can stop these strictures from forming. The study will compare two different strengths (doses) of this budesonide tablet against a placebo. A placebo is a 'dummy' tablet that looks identical to the active medicine but contains no drug. This helps us to be sure that any effects we see are genuinely due to the budesonide.
The main thing we want to find out is how many people who take the budesonide or the placebo are free of these strictures after 8 weeks. We'll also be looking at other things, like how many times someone might need a procedure to widen their food pipe if a stricture does form. This is an early stage, or 'Phase II', study, meaning we are exploring if the medicine works and is safe before doing larger studies.
Key takeaways
- The study tests a new medicine to prevent food pipe narrowing.
- It's for people who have had a specific stomach procedure.
- You might receive the active medicine or a dummy pill.
- The treatment period is 8 weeks, with follow-up checks.
- This is an early stage study to see if the medicine works.
- Your participation could help improve future treatments.
Who may be eligible?
To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also be considered.
Both men and women can participate in this research. The study needs people who have recently undergone the specific stomach procedure called endoscopic submucosal dissection. This is because the study is focused on preventing a specific complication that can occur after this procedure.
Other specific health requirements, like certain medical conditions or medications you might be taking, will be carefully checked by the study doctors. They will make sure the study is right and safe for you.
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.
- Are you 18 years old or older?
- Have you recently undergone an endoscopic submucosal dissection procedure?
- Are you able to attend regular study visits?
- Are you comfortable potentially receiving a placebo (dummy pill)?
What does participation involve?
If you decide to take part, you'll be given either one of two doses of the budesonide medicine or a placebo, which looks identical but contains no active drug. Neither you nor your study doctor will know which one you are taking; this is called 'double-blind'. You'll take this medicine for 8 weeks.
Throughout the study, you'll have regular visits with the study team. These visits will involve checks to see if any strictures have formed in your food pipe. They will also monitor your overall health and any side effects you might experience. These checks might include physical examinations and sometimes further scans or procedures if needed. After the 8 weeks of treatment, there will be a follow-up visit to continue monitoring your progress. The total length of your involvement in the study will be discussed with you, including all treatment and follow-up periods.
Potential risks and benefits
Locations (7)
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedPortugal
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is an oesophageal stricture?
It's a narrowing of your food pipe (oesophagus) that can make swallowing difficult. It can sometimes happen after certain stomach procedures.
What is an endoscopic submucosal dissection?
It's a procedure where doctors remove growths or early cancers from the lining of your food pipe using a thin, flexible tube called an endoscope.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are taking the active medicine or the dummy pill (placebo). This helps make the study results more reliable.
What is a placebo?
A placebo is a 'dummy' tablet that looks exactly like the study medicine but contains no active drug. It helps compare the real medicine's effects.
How long will I be involved in the study?
You'll take the study medicine for 8 weeks, with regular visits during that time, followed by at least one follow-up visit afterwards.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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