Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
Conditions
Keywords
Xerostomia, Pilocarpine, advanced age (≥ 70 years)
Brief summary
The investigators intended for this study to deliver the proof-of-concept that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.
Interventions
DRUGPilocarpine Ophthalmic Solution
1. low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day 2. high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 70 years of age * Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.
Exclusion criteria
* Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician * Inability to fill out the questionnaires due to other reasons * Prior radiation therapy of the head-and-neck region * Known m. Sjögren disease * Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in xerostomia score (Numeric Rating Scale) | 3 weeks | The Numeric Rating Scale is used to quantify the level of severity of xerostomia using a 0-10 cm Numeric Rating Scale ranging from 0 = no dry mouth to 10 = worst possible dry mouth |
| Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index) | 2 weeks | Questionnaires assessing Oral health-related quality of life of adults, in particular older people is measured 4 times during this study by the doctor/research nurse . It comprises 12 items that measure three dimensions of Oral health-related quality of life: physical function items, psychosocial function and pain/discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 3 weeks | adverse events or other symptoms |
| Global perceived effect | 3 weeks | The Global perceived effect scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. |
Countries
Netherlands
Outcome results
None listed