NCT05506137

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.1 years

First QC Date

August 16, 2022

Last Update Submit

August 16, 2022

Conditions

XerostomiaDry Mouth

Keywords

XerostomiaDry mouthPilocarpine

Outcome Measures

Primary Outcomes (1)

  • The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.

    A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS

    4 weeks

Secondary Outcomes (9)

  • Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group

    4 - 12 weeks

  • Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group

    4 - 12 weeks

  • Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group

    4 - 12 weeks

  • Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group

    4 - 12 weeks

  • Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group

    4 - 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL
Drug: Pilocarpine

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

PilocarpineDRUG

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Treatment
PlaceboOTHER

study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have a life-limiting condition or frailty
  • have the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0= no dry mouth to 10= worst dry mouth ever)
  • fulfil the single SQ 'Would I be surprised if my patient dies within the year? (no)

You may not qualify if:

  • their life expectancy is less than 4 weeks (the primary endpoint at 4 weeks)
  • they have had radiotherapy to the salivary glands or suffer from Sjögrens disease (impact on dry mouth)
  • cognitively impaired to such an extent that there is insufficient understanding to complete questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Theunissen M, Rideaux-Seferina S, Magdelijns FJ, Janssen DJA, van den Beuken-van Everdingen MHJ. Local Oral Pilocarpine Drops for Relieving Xerostomia (Dry Mouth) in the Elderly: A Pilot Study. J Am Med Dir Assoc. 2021 Jan;22(1):185-186. doi: 10.1016/j.jamda.2020.06.036. Epub 2020 Aug 13. No abstract available.

    PMID: 32800514BACKGROUND

  • van der Meulen AI, Neis EPJG, de Nijs EJM, Coenegracht BJEG, Stoppelenburg A, van den Beuken-van Everdingen MHJ, van der Linden YM. Dry mouth in patients with a life-limiting condition or frailty: a study protocol for two intervention studies and a nested qualitative sub-study (the Dry mOuth Project, DROP). BMC Palliat Care. 2023 Aug 23;22(1):120. doi: 10.1186/s12904-023-01242-0.

    PMID: 37612654DERIVED

Related Links

MeSH Terms

Conditions

Xerostomia

Interventions

Pilocarpine

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Marieke van den Beuken- van Everdingen, Prof.

    Maastricht University and/or Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke van den Beuken- van Everdingen, Prof.

CONTACT

0031(0)43 3877392m.vanden.beuken@mumc.nl

Evelien Neis, Dr.

CONTACT

0031(0)43 3875610evelien.neis@mumc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

January 1, 2023

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share