Local Pilocarpine for Relieving Dry Mouth
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Low dose pilocarpine low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day |
Drug: Pilocarpine Ophthalmic Solution
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
|
Active Comparator: High dose pilocarpine high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day |
Drug: Pilocarpine Ophthalmic Solution
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 70 years of age
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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:
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Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
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Inability to fill out the questionnaires due to other reasons
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Prior radiation therapy of the head-and-neck region
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Known m. Sjögren disease
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Maastricht University Medical Centre | Maastricht | Limburg | Netherlands | 6202 AZ Maastricht |
Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
- Principal Investigator: Marieke van den Beuken, Prof, Maastricht University Medical Centre
Study Documents (Full-Text)
More Information
Publications
None provided.- METC18-071