Trial · NCT05506137
Xerostomia in Patients With a Life-limiting Condition or Frailty
NCT05506137, Phase 3, Unknown, Maastricht University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Xerostomia in Patients With a Life-limiting Condition or Frailty. Trials, record NCT05506137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05506137
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Xerostomia in Patients With a Life-limiting Condition or Frailty
- NCT number
- NCT05506137
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Maastricht University Medical Center
- Conditions
- Xerostomia, Dry Mouth
- Interventions
- Pilocarpine, Placebo
- First posted
- 2022-08-18
- Last updated
- 2022-08-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The percentage responders at week 4 of topical pilocarpine administration, as compared to baseline. | 4 weeks | A patient counts as a responder with, at least, a 2-point reduction on the 11-point NRS |
| Secondary | Mean difference in NRS dry mouth scores in the pilocarpine group at all time-points, as compared to the placebo group | 4 - 12 weeks | Mean difference in NRS dry mouth scores is determined as mean change from baseline |
| Secondary | Change in Oral Health-Related Quality of Life (OHRQoL) upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | The OHRQoL is measured using the Geriatric Oral Health Assessment Index (GOHAI-NL) |
| Secondary | Change in the Health-Related Quality of Life upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | The HRQoL will be assessed using the EQ-5D-5L questionnaire |
| Secondary | Change in clinical functioning upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | Clinical functioning is determined using the Patient-reported functional status (PRFS) questionnaire |
| Secondary | Change in the Global Perceived Effect (GPE) upon pilocarpine treatment, as compared to the placebo group | 4 - 12 weeks | The GPE is determined by a globally experienced effect score |
| Secondary | The durability of the effect of the use of pilocarpine on xerostomia | 4 - 12 weeks | The durability will be displayed in percentage |
| Secondary | The adherence rate of patients | 4 -12 weeks | Adherence will be displayed in percentage |
| Secondary | Possible side effects related to the intake of pilocarpine medication, as compared to the placebo group | 4 - 12 weeks | Side effects are made transparent by providing an overview of which and how many side effects occur |
| Secondary | Cost Effectiveness Analysis (CEA) of the pilocarpine treatment | 4 - 12 weeks | The costst of patients is analysed using the medical consumption questionnaire (iMCQ) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05506137
GET https://conductscience.org/api/trials/v1/NCT05506137/registered