Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Xerostomia in patients with a life-limiting condition or frailty: a double-blind placebo-controlled randomized clinical trial

This study is a major test of a medicine called pilocarpine. It's for adults who experience dry mouth because of a serious illness or general weakness. Researchers want to see if pilocarpine drops, taken by mouth three times a day, can significantly reduce dry mouth symptoms compared to a dummy treatment (placebo). They're especially interested in how many people feel a noticeable improvement after four weeks. The study will also check for side effects, how the medicine affects daily life and overall well-being, and its cost-effectiveness. This is a very important step to confirm if pilocarpine could be a helpful treatment for this common and uncomfortable problem.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Hospital Maastricht

Enrolment target

120

Start

21 Mar 2023

Adult patients with a life-limiting condition or frailty who have the complaint dry mouth

What is this study about?

Imagine you have a dry mouth that just won't go away, perhaps because you're dealing with a serious illness or generally feeling a bit frail. This can be really uncomfortable, making it hard to talk, eat, and swallow. This important study, called a "Phase III trial," is looking into a medicine called pilocarpine to see if it can help.

The main idea is to find out if taking pilocarpine as oral drops can make a real difference to how dry your mouth feels. Participants will take the drops three times a day for several weeks. Some people will get the actual medicine, while others will get a 'dummy' medicine (a placebo) that looks and tastes the same but has no active ingredients. This helps researchers fairly compare the effects of the actual medicine. The study will particularly focus on whether people feel a significant improvement in their dry mouth after four weeks.

Beyond just measuring dry mouth, the researchers are also keen to understand how pilocarpine might affect other aspects of your life. They'll look at your overall quality of life, your ability to do daily activities, and if there are any side effects. They'll also consider how easy it is to stick to the treatment plan and what people think about using pilocarpine for dry mouth. All this information helps doctors decide if pilocarpine is a truly beneficial and practical treatment.

Key takeaways

Tests pilocarpine drops for dry mouth caused by serious illness or frailty.
Compares pilocarpine to a dummy treatment (placebo).
Focuses on how many people feel better after four weeks.
Investigates side effects and impact on daily life.
Aims to confirm if pilocarpine is an effective treatment.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older. There's no upper age limit, so older adults are welcome to participate if they meet the other criteria.

To join, you need to be experiencing dry mouth. This dry mouth must be a result of either a serious, life-limiting condition or general frailty (meaning you're feeling weak or not as strong as you used to be).

If you have dry mouth and fit this description, you might be able to take part. The study team will check your full medical history to make sure it's safe and suitable 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?
Do you experience dry mouth?
Is your dry mouth due to a serious medical condition or general weakness?
Are you able to take drops by mouth three times a day?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given drops to take by mouth three times a day. You won't know if you're getting the active medicine (pilocarpine) or a dummy treatment (placebo), and neither will your doctors. You'll need to attend regular appointments where you'll be asked about your dry mouth symptoms using a simple scale, and how you're feeling overall. These assessments will happen over several weeks, likely at weeks 2, 4, 8, and 12 from when you start the drops. The total time you'll be involved in the study will be about 12 weeks. You'll also be asked questions about any side effects you might experience, how well you're taking the drops, and what you think about the treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from an improvement in your dry mouth symptoms if you receive the active medicine. Even if you receive the dummy medicine, you'll get regular check-ups and contribute to important medical research that could help others in the future. Potential risks might include side effects from the medication, which the study will carefully monitor. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is 'dry mouth' and why is it a problem?

Dry mouth, also called xerostomia, means you don't produce enough saliva. It can make eating, swallowing, and talking difficult, and can also lead to dental problems.

What is pilocarpine?

Pilocarpine is a medicine that helps your body produce more saliva. It's used in this study as drops you take by mouth.

What is a 'life-limiting condition' or 'frailty'?

A life-limiting condition is an illness that can't be cured. Frailty means your body is generally weaker and less resilient. Both can sometimes cause dry mouth.

What does 'double-blind, placebo-controlled' mean?

It means neither you nor your doctors will know if you're getting the actual medicine or a dummy treatment (placebo). This helps make the study results fair and accurate.

How long will I be involved in the study?

If you join, you'll be followed for about 12 weeks, with regular check-ups during that time.