Local Pilocarpine for Relieving Dry Mouth

Early Phase 1

Completed

• Conditions: Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
• Interventions: Drug: Pilocarpine Ophthalmic Solution

• Registration Number: NCT04195100
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-12-01
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Completion: 2020-01-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose pilocarpine	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	Pilocarpine Ophthalmic Solution	high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands