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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
mond, keelholte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in xerostomia score
Change in oral health-related quality of life
Secondary outcome
- Adverse effects
- Other symptoms
- Global perceived effect
Background summary
This study intents 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 expense of a minimum of side effects. To this end,
the study aims to quantify the effect size of pilocarpine in two different
dosages. In case we observe clinically meaningful changes in xerostomia, a
well-powered RCT will be prepared to compare pilocarpine to placebo .
Study 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.
Study design
Open-label randomised controlled pilot study
Intervention
Local administration of pilocarpine (eye)drops orally in a low dose group or
a high dose for 14 days
Study burden and risks
The extent of the burden associated with participation in this study is
considered to be low. Total follow up will last a total of 3 weeks. In these 3
weeks the patient will visit the hospital twice and will be contacted through
phone calls twice. Local oral administration of pilocarpine is reported to have
none or only minor side effects. During the two hospital visits whole resting
saliva will be collected, and blood pressure will be measured. The burden of
both these procedures is considered low. The patient will also be asked to
complete a total of four questionnaires in these 3 weeks. These questionnaires
will consist of 45 questions which will take 20 minutes each.
P. Debeylaan 25
Maastricht 6229HX
NL
P. Debeylaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004352-38-NL |
| CCMO | NL68313.068.18 |