NCT04195100

Local Pilocarpine for Relieving Dry Mouth

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pilocarpine Ophthalmic Solution	1. low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day 2. high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-12-01
• Completion: 2020-01-31
• First posted: 2019-12-11
• Last updated: 2020-02-28

Locations

1 site across 1 country: Netherlands