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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Determining the optimal strategy for stopping chronic proton pump inhibitor therapy in primary care patients: impact of on-demand use, adjustment of therapy or discontinuation.

This study aims to find the most effective way for people using long-term heartburn medication, called Proton Pump Inhibitors (PPIs), to stop taking it safely and comfortably. It's for patients in regular GP surgeries who experience problems like heartburn, indigestion, or reflux. Researchers are comparing different methods: some people might try taking their medication only when they need it, others might gradually reduce their dose, and some might stop completely. They want to see which approach leads to patients feeling best, being happy with their treatment, and not needing to restart their PPIs. The study will also look at how satisfied patients are and how often they use medicine for their symptoms.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
UZ Leuven
Enrolment target
745
Start
12 Apr 2023

What is this study about?

Heartburn, indigestion, and reflux are common problems that can be managed with medicines called Proton Pump Inhibitors, or PPIs. Many people take these medicines for a long time. This study is all about helping people who take PPIs regularly to find the best way to stop using them, or to take them less often, if that's right for them.

The researchers want to understand if taking PPIs only when you need them, slowly reducing the dose, or stopping them completely works best. They will be looking at how patients feel about these different approaches, whether their symptoms are well controlled, and if they are happy with their treatment plan. The main goal is to find a way that helps people manage their symptoms without relying on PPIs long-term, which can sometimes have side effects.

This is called a 'Phase IV' study, which means the medications being looked at are already approved and widely used. The study isn't testing new drugs, but rather different ways of using existing ones to help patients manage their conditions more effectively and safely. The results will help doctors and patients in the UK decide the best approach for reducing or stopping long-term PPI use in general practice.

Key takeaways

  • Aims to find the best way to reduce or stop long-term heartburn medication (PPIs).
  • Compares different approaches: 'on-demand' use, gradual reduction, or stopping completely.
  • Focuses on patient satisfaction and comfort, alongside symptom control.
  • Involves adults with heartburn, indigestion or reflux, currently using PPIs.
  • May involve using antacids (e.g., Maalox, Gaviscon) to manage symptoms.
  • Will help GPs better advise patients on PPI use in the future.

Who may be eligible?

This study is open to adults aged 18 years and older. Both men and women can take part.

You might be able to join if you regularly experience heartburn, indigestion (dyspepsia), or reflux, and you are currently taking Proton Pump Inhibitor (PPI) medication for these conditions. The study is particularly interested in people who are being looked after by their local GP practice.

More specific details about who can and cannot join would be discussed with you by the study team or your doctor to make sure it's the right fit 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.

  1. Are you 18 years old or older?
  2. Do you experience heartburn, indigestion, or reflux?
  3. Are you currently taking a Proton Pump Inhibitor (PPI) medication for these symptoms?
  4. Are you looked after by your GP for your medical care?
  5. Are you interested in potentially reducing or stopping your PPI medication?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a chat with the study team to make sure it's suitable for you. You would then be put into one of the different groups, which might involve trying to take your PPI medication differently – for example, only when you need it, or gradually reducing your dose. You might also be given some antacid medications like Maalox or Gaviscon, to help with any symptoms if you reduce or stop your PPIs.

Throughout the study, you would have regular follow-up visits or check-ins. During these appointments, the study team would ask you about your symptoms, how satisfied you are with your treatment, and how often you're using your medication. The study will last for a certain period, and the team will track your progress and how you're feeling over this time. The total duration of your involvement will be explained to you before you agree to take part.

Potential risks and benefits

Taking part in this study might help you find a better way to manage your heartburn or indigestion, potentially reducing your reliance on long-term medication and improving your quality of life. However, there's always a chance that reducing or stopping your current medication could cause your symptoms to return or worsen temporarily. The study will use antacid medications to help manage such symptoms. As with any study, you are free to stop taking part at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What are PPIs?

PPIs are medicines like omeprazole or lansoprazole that reduce the amount of acid your stomach makes, helping to treat heartburn and indigestion.

Why is this study important?

It helps doctors understand the safest and most comfortable ways for people to reduce or stop long-term PPI use, which can improve their overall health.

Will I have to stop my medication immediately?

Not necessarily. The study is looking at different approaches, including gradually reducing your dose or only taking medication when you need it.

What if my symptoms come back?

The study provides other medications, like antacids, to help manage any symptoms that might return if you reduce or stop your PPIs.

How long will the study last?

The exact duration of your involvement will be explained by the study team, but it will involve a period of follow-up to see how you are doing.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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