drugset / Trial / NCT04195100

Local Pilocarpine for Relieving Dry Mouth

NCT04195100

Phase 0 Completed 14 enrolled Maastricht University Medical Center
RandomizedParallel-groupOpen-labelSupportive care

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.

Timeline

Start
2019-04-01
Primary completion
2019-12-01
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pilocarpine Unknown 2 mg Other
Comparator Pilocarpine Unknown 5 mg Other

Indications

No indication recorded.