Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05506137
Other study ID # 2022-501084-41-00
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 2023
Est. completion date June 2025

Study information

Verified date August 2022
Source Maastricht University Medical Center
Contact Marieke van den Beuken- van Everdingen, Prof.
Phone 0031(0)43 3877392
Email m.vanden.beuken@mumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 4 - 12 weeks
Secondary 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) 4 - 12 weeks
Secondary 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 4 - 12 weeks
Secondary 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 4 - 12 weeks
Secondary 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 4 - 12 weeks
Secondary The durability of the effect of the use of pilocarpine on xerostomia The durability will be displayed in percentage 4 - 12 weeks
Secondary The adherence rate of patients Adherence will be displayed in percentage 4 -12 weeks
Secondary 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 4 - 12 weeks
Secondary Cost Effectiveness Analysis (CEA) of the pilocarpine treatment The costst of patients is analysed using the medical consumption questionnaire (iMCQ) 4 - 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05342272 - Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction Phase 3
Completed NCT03302676 - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors N/A
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Completed NCT01272570 - Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors N/A
Completed NCT00656513 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00911768 - Effect of Korean Red Ginseng (KRG) on Dry Mouth Phase 4
Completed NCT00332618 - Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia Phase 2
Completed NCT03494985 - A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water N/A
Completed NCT05058430 - SaliPen Human Factors Study for OTC Labeling N/A
Recruiting NCT02705937 - Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications. N/A
Completed NCT05247008 - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD N/A
Recruiting NCT03632096 - Photobiomodulation in Salivary Production of Patients With Xerostomy Phase 2
Not yet recruiting NCT04323384 - The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing N/A
Not yet recruiting NCT03530735 - Finger-prick Autologous Blood (FAB) for Use in Dry Mouth N/A
Active, not recruiting NCT03176368 - Coconut Oil: Managing Radiation-Induced Xerostomia N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Completed NCT02682199 - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn NCT01960101 - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication N/A
Completed NCT02317172 - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases N/A

External Links