XerostomiaPhase 3NCT05506137
Xerostomia in Patients With a Life-limiting Condition or Frailty
A Phase 3 study testing Pilocarpine in people with Xerostomia and Dry Mouth, run by Maastricht University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Dry Mouth
- What is being tested?
- Pilocarpine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial
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
- Being tested
- Pilocarpine, Placebo
- Keywords
- Xerostomia, Dry mouth, Pilocarpine
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
PlaceboOther
study whether topical pilocarpine drops induce a clinically significant improvement in xerostomia
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Pilocarpine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Mean difference in NRS dry mouth scores is determined as mean change from baseline
Measured: 4 - 12 weeks
Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
The OHRQoL is measured using the Geriatric Oral Health Assessment Index (GOHAI-NL)
Measured: 4 - 12 weeks
Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
The HRQoL will be assessed using the EQ-5D-5L questionnaire
Measured: 4 - 12 weeks
Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
Clinical functioning is determined using the Patient-reported functional status (PRFS) questionnaire
Measured: 4 - 12 weeks
Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
The GPE is determined by a globally experienced effect score
Measured: 4 - 12 weeks
The durability of the effect of the use of pilocarpine on xerostomia
The durability will be displayed in percentage
Measured: 4 - 12 weeks
The adherence rate of patients
Adherence will be displayed in percentage
Measured: 4 -12 weeks
Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
Side effects are made transparent by providing an overview of which and how many side effects occur
Measured: 4 - 12 weeks
Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
The costst of patients is analysed using the medical consumption questionnaire (iMCQ)
Measured: 4 - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study startJan 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Marieke van den Beuken- van Everdingen, Prof., Principal investigator, Maastricht University and/or Maastricht UMC+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506137
- Sponsor's protocol ID
- 2022-501084-41-00
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32800514van 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.
PubMed 37612654
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xerostomia in Patients With a Life-limiting Condition or Frailty: a Double-blind Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05506137
- Acronym / sponsor ID
- 2022-501084-41-00
- Conditions
- Xerostomia, Dry Mouth
- Keywords
- Xerostomia, Dry mouth, Pilocarpine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Pilocarpine |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilocarpinestudy whether topical pilocarpine drops induce a clinically significant improvement in xerostomia | Drug | Treatment |
| Placebostudy whether topical pilocarpine drops induce a clinically significant improvement in xerostomia | Other | Placebo |
Primary outcome
The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline.
Time frame: 4 weeks
A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS
9 secondary outcomes
Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group
Time frame: 4 - 12 weeks
Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group
Time frame: 4 - 12 weeks
Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group
Time frame: 4 - 12 weeks
Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group
Time frame: 4 - 12 weeks
Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group
Time frame: 4 - 12 weeks
The durability of the effect of the use of pilocarpine on xerostomia
Time frame: 4 - 12 weeks
The adherence rate of patients
Time frame: 4 -12 weeks
Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group
Time frame: 4 - 12 weeks
Cost Effectiveness Analysis (CEA) of the pilocarpine treatment
Time frame: 4 - 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 32800514Theunissen 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.
- Derived from this study: PubMed 37612654van 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.
- ZonMW Programma PalliantieLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marieke van den Beuken- van Everdingen, Prof. principal investigator
Maastricht University and/or Maastricht UMC+
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilocarpine in people with Xerostomia and Dry Mouth, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marieke van den Beuken- van Everdingen, Prof. (0031(0)43 3877392, m.vanden.beuken@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05506137, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.