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Completed

NCT Number: NCT04195100

Local Pilocarpine for Relieving Dry Mouth

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.

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Key information

Conditions

Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilocarpine Ophthalmic Solution

Drug
  • 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 outcomes

  1. Change in xerostomia score (Numeric Rating Scale)

    Time frame: 3 weeks

    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

  2. Change in oral health-related quality of life (Dutch Geriatric Oral Health Assessment Index)

    Time frame: 2 weeks

    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 outcomes

  1. Adverse effects

    Time frame: 3 weeks

    adverse events or other symptoms

  2. Global perceived effect

    Time frame: 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Local Application of Pilocarpine for Relieving Dry Mouth Complaints: A Randomized Controlled Pilot Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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