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Xerostomia in patients with a life-limiting condition or frailty: a double-blind placebo-controlled randomized clinical trial
EU CTIS ID: 2022-501084-41-00
What this study is testing
This study intents to evaluate the effect of locally administered oral pilocarpine drops (3x 6 oral drops of pilocarpine per day ) in reducing complaints of dry mouth in a palliative population with xerostomia at the expense of limited adverse events, as compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years or older
- have a life-limiting condition or frailty
- have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever)
- fulfil the single SQ ‘Would I be surprised if my patient dies within the year? (no)
You likely can't join if
- a life expectancy of less than 4 weeks (the primary endpoint at 4 weeks)
- have/had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth)
- cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.