Local Pilocarpine for Relieving Dry Mouth
Primary Purpose
Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
Status
Completed
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Pilocarpine Ophthalmic Solution
Sponsored by
About this trial
This is an interventional supportive care trial for Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth focused on measuring Xerostomia, Pilocarpine, advanced age (≥ 70 years)
Eligibility Criteria
Inclusion Criteria:
- ≥ 70 years of age
- Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.
Exclusion Criteria:
- Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
- Inability to fill out the questionnaires due to other reasons
- Prior radiation therapy of the head-and-neck region
- Known m. Sjögren disease
- Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
Sites / Locations
- Maastricht University Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low dose pilocarpine
High dose pilocarpine
Arm Description
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Outcomes
Primary Outcome Measures
Change in xerostomia score (Numeric Rating Scale)
The Numeric Rating Scale is used to quantify the level of severity of xerostomia using a 0-10 cm Numeric Rating Scale ranging from 0 = no dry mouth to 10 = worst possible dry mouth
Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)
Questionnaires assessing Oral health-related quality of life of adults, in particular older people is measured 4 times during this study by the doctor/research nurse . It comprises 12 items that measure three dimensions of Oral health-related quality of life: physical function items, psychosocial function and pain/discomfort.
Secondary Outcome Measures
Adverse effects
adverse events or other symptoms
Global perceived effect
The Global perceived effect scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point.
Full Information
NCT ID
NCT04195100
First Posted
December 4, 2019
Last Updated
February 26, 2020
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04195100
Brief Title
Local Pilocarpine for Relieving Dry Mouth
Official Title
Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A Randomized Controlled Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators intended for this study to deliver the "proof-of-concept" that locally administered pilocarpine drops in two doses are effective in a population of elderly (aged ≥ 70 years) with xerostomia at the expense of limited adverse events. To this end, the study aims to quantify the effect size of pilocarpine in two different dosages. In case the investigators observe clinically meaningful changes in xerostomia through measured NRS, a sufficiently-powered RCT will be prepared to compare pilocarpine to placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth
Keywords
Xerostomia, Pilocarpine, advanced age (≥ 70 years)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose pilocarpine
Arm Type
Active Comparator
Arm Description
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
Arm Title
High dose pilocarpine
Arm Type
Active Comparator
Arm Description
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Intervention Type
Drug
Intervention Name(s)
Pilocarpine Ophthalmic Solution
Intervention Description
low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day
Primary Outcome Measure Information:
Title
Change in xerostomia score (Numeric Rating Scale)
Description
The Numeric Rating Scale is used to quantify the level of severity of xerostomia using a 0-10 cm Numeric Rating Scale ranging from 0 = no dry mouth to 10 = worst possible dry mouth
Time Frame
3 weeks
Title
Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)
Description
Questionnaires assessing Oral health-related quality of life of adults, in particular older people is measured 4 times during this study by the doctor/research nurse . It comprises 12 items that measure three dimensions of Oral health-related quality of life: physical function items, psychosocial function and pain/discomfort.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Adverse effects
Description
adverse events or other symptoms
Time Frame
3 weeks
Title
Global perceived effect
Description
The Global perceived effect scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥ 70 years of age
Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.
Exclusion Criteria:
Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician
Inability to fill out the questionnaires due to other reasons
Prior radiation therapy of the head-and-neck region
Known m. Sjögren disease
Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marieke van den Beuken, Prof
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ Maastricht
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
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Local Pilocarpine for Relieving Dry Mouth
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