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Study on Pilocarpine Hydrochloride for Dry Mouth in Adults with Life-Limiting Conditions or Frailty

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What is this study about?

This clinical trial is focused on studying xerostomia, commonly known as dry mouth, in adults who have a life-limiting condition or are experiencing frailty. The treatment being tested is pilocarpine hydrochloride, which is administered as oral drops. The purpose of the study is to evaluate how effective these drops are in reducing the discomfort of dry mouth compared to a placebo.

Participants in the study will receive the treatment of pilocarpine hydrochloride three times a day for a period of four weeks. The study aims to observe any changes in the severity of dry mouth symptoms and to assess the overall impact on the participants’ quality of life. The study will also monitor any side effects that may occur from using pilocarpine hydrochloride.

The trial will measure the effectiveness of the treatment by looking at the reduction in dry mouth symptoms and improvements in oral health-related quality of life. Participants’ feedback on the treatment’s applicability and any potential side effects will also be collected. The study will continue to follow participants for up to 12 weeks to evaluate the long-term effects of the treatment.

1 beginning of the trial

Upon joining the study, participants will be randomly assigned to receive either the active medication, pilocarpine hydrochloride, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the active medication or placebo.

2 medication administration

Participants will take pilocarpine hydrochloride orally in the form of drops. The dosage is 6 oral drops, three times a day. This regimen will continue for a period of 4 weeks.

3 week 4 assessment

At the end of week 4, the primary endpoint will be evaluated. This involves assessing the percentage of participants who experience a clinically relevant reduction in dry mouth symptoms, defined as at least a 2-point decrease on an 11-point numerical rating scale.

4 continuation and further assessments

Participants who initially received pilocarpine may continue with the treatment for up to 12 weeks. Assessments will occur at weeks 8 and 12 to evaluate the ongoing effects of the medication.

Secondary endpoints will be measured, including changes in dry mouth severity, oral health-related quality of life, and overall health-related quality of life. These assessments will be conducted using various questionnaires and scales.

5 monitoring and feedback

Throughout the trial, participants will be monitored for any side effects related to the medication. Feedback on the applicability and effectiveness of pilocarpine in reducing dry mouth symptoms will be collected at weeks 4, 8, and 12.

Adherence to the medication regimen will also be tracked, and participants’ views on the treatment will be gathered to assess its cost-effectiveness.

Who Can Join the Study?

  • Must be 18 years or older.
  • Have a life-limiting condition or be frail. This means having a serious illness that affects daily life or being physically weak.
  • Experience dry mouth with a score of 5 or more on a scale from 0 to 10, where 0 means no dry mouth and 10 means the worst dry mouth ever.
  • Meet the condition where the healthcare provider would not be surprised if the patient might pass away within a year.

Who Cannot Join the Study?

  • Patients who are not adults cannot participate.
  • Patients who do not have a life-limiting condition or frailty with the complaint of dry mouth cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
University Hospital Maastricht Maastricht The Netherlands

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.03.2023

Trial locations

Investigated drugs:

Pilocarpine is a medication used in this clinical trial to help reduce the feeling of dry mouth, which is a common problem for people with certain serious health conditions. It works by stimulating the glands in your mouth to produce more saliva, which can help make your mouth feel more comfortable and moist. In this study, pilocarpine is given as oral drops that you take several times a day. The goal is to see if it can help people feel better without causing too many side effects.

Investigated diseases:

Xerostomia – Xerostomia, commonly known as dry mouth, is a condition characterized by a decrease in saliva production. This can lead to difficulties in speaking, chewing, and swallowing, as well as an increased risk of dental cavities and oral infections. The condition often progresses gradually, with symptoms becoming more pronounced over time. Patients may experience a persistent dry or sticky feeling in the mouth, a burning sensation, or a dry throat. As xerostomia progresses, it can significantly impact oral health and overall quality of life. The condition is often associated with other health issues or as a side effect of certain medications.

Trial ID:
2022-501084-41-00
Protocol code:
2022-501084-41-00
NCT ID:
NCT05506137
Trial Phase:
Therapeutic confirmatory (Phase III)

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