Treatment of dry mouth with local pilocarpine drops

Phase 1

• Conditions: xerostomia; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2018-004352-38-NL
• Lead Sponsor: Centraal Ziekenfonds (CZ) health insurance company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 24

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

• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> ;<br> Secondary Objective: the study aims to quantify the effect size of pilocarpine in two different dosages.<br> ;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 Outcome Measures

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