Treatment of dry mouth with local pilocarpine drops

Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A randomized controlled pilot trial - xero2019

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004352-38-NL

Enrollment

Registered

2019-02-25

Start date

2020-01-13

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

xerostomia

Interventions

Trade Name: Minims Pilocarpine Nitrate 2%w/v Eye Drops, Solution Product Name: Minims Pilocarpine Nitrate 2%w/v Eye Drops, Solution Product Code: PL 03468/0078

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

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
Main Objective: The objective of this study is to deliver the “proof-of-concept” that locally administered pilocarpine drops are effective in a population of elderly with xerostomia at expense of a minimum of side effects. ; Secondary Objective: the study aims to quantify the effect size of pilocarpine in two different dosages. ;Primary end point(s): - change in xerostomia score (NRS) - change in oral health-related quality of life (GOHAI-NL);Timepoint(s) of evaluation of this end point: 3 weeks	—

Measure

Time frame

Main Objective: The objective of this study is to deliver the “proof-of-concept” that locally administered pilocarpine drops are effective in a population of elderly with xerostomia at expense of a minimum of side effects. ; Secondary Objective: the study aims to quantify the effect size of pilocarpine in two different dosages. ;Primary end point(s): - change in xerostomia score (NRS) - change in oral health-related quality of life (GOHAI-NL);Timepoint(s) of evaluation of this end point: 3 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - Adverse effects - Other symptoms - Global perceived effect;Timepoint(s) of evaluation of this end point: 3 weeks	—

Countries

Netherlands

Contacts

Public ContactProfessor Palliative Medicine

MUMC+

m.vanden.beuken@mumc.nl+31433877392

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026