NCT05506137

Xerostomia in Patients With a Life-limiting Condition or Frailty

Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Xerostomia, the subjective feeling of dry mouth, is a common symptom during the last year of life in patients with a life-limiting condition or frailty. Xerostomia leads to functional alterations (such as burning sensations, an altered taste perception, and difficulties with chewing, swallowing, and speaking), has disabling social consequences and significantly downgrades the perceived quality of life. It is an under-exposed and under-treated symptom often caused by alterations in the quality and quantity of saliva. Locally administered pilocarpine could be a promising drug in this regard as it alleviates xerostomia by increasing the production of saliva.

Conditions

• Xerostomia
• Dry Mouth

Interventions

Type	Name	Description
DRUG	Pilocarpine	study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
OTHER	Placebo	study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2022-08-18
• Last updated: 2022-08-18