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Xerostomia in Patients With a Life-limiting Condition or Frailty

NCT05506137 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marieke van den Beuken- van Everdingen, Prof. · Maastricht University and/or Maastricht UMC+

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-02-28
Completion
2025-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506137 on ClinicalTrials.gov