Local Pilocarpine for Relieving Dry Mouth

Early Phase 1CompletedNCT04195100

Maastricht University Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth

Interventions

Pilocarpine Ophthalmic SolutionDRUG

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

Eligibility

Sex: ALLMin age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

Change in xerostomia score (Numeric Rating Scale)

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

Time frame: 3 weeks

Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)

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.

Time frame: 2 weeks

Secondary Outcomes

Adverse effects

adverse events or other symptoms

Time frame: 3 weeks

Global perceived effect

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.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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