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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

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

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Learn more about this trial

Local Pilocarpine for Relieving Dry Mouth

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