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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48076
Enrollment
24
Registered
2019-02-06
Start date
2019-06-03
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

mond, keelholte dry mouth xerostomia

Interventions

Local administration of pilocarpine (eye)drops orally in a low dose group or a high dose for 14 days

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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.

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

Secondary

MeasureTime frame
- Adverse effects - Other symptoms - Global perceived effect

Primary

MeasureTime frame
Change in xerostomia score Change in oral health-related quality of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)