Local Pilocarpine for Relieving Dry Mouth

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

Official title:

Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195100
• Other study ID #: METC18-071
• Status: Completed
• Phase: Early Phase 1
• Start date: April 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 31, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients of Advanced Age (= 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks
Primary	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.	2 weeks
Secondary	Adverse effects	adverse events or other symptoms	3 weeks
Secondary	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.	3 weeks