Xerostomia in patients with a life-limiting condition or frailty:a double-blind placebo-controlled randomized clinical trial
Phase 1
Recruiting
- Conditions
- Adult patients with a life-limiting condition or frailty who have the complaint dry mouthTherapeutic area: Not possible to specify
- Registration Number
- CTIS2022-501084-41-00
- Lead Sponsor
- niversity Hospital Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
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)
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method