What side effects are associated with this type of intervention?

Anticholinergic agents, such as atropine gel, are commonly used to treat drooling by reducing saliva production. However, they can cause several side effects, including dry mouth, blurred vision, constipation, urinary retention, and confusion, particularly in older adults. Additionally, topical formulations like atropine gel may cause localized irritation in the oral cavity.

What prior FDA approvals exist?

FDA-approved treatments for drooling, particularly in conditions like Parkinson's disease, include anticholinergic agents such as ipratropium bromide. Ipratropium bromide spray has been studied for its efficacy in reducing saliva production and is administered as a nasal spray. Other anticholinergic agents, like atropine, have been explored in various formulations, including oral gels, for their potential to manage sialorrhea by reducing saliva secretion.

What other types of research exist?

Promising novel alternatives to Atropine Gel for drooling patients may include: 1) Mucoadhesive buccal films, which have shown improved therapeutic delivery in other conditions, such as the use of almotriptan for migraines. 2) Intranasal gels, which have demonstrated enhanced bioavailability and brain localization in treatments for conditions like Parkinson's disease. These delivery systems could potentially be adapted for anticholinergic agents to manage drooling more effectively.

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Anticholinergic

Pharmacokinetics Study of Atropine Oral Gel

Q: What is the mechanism of action of this treatment?

Anticholinergic agents, such as Atropine Gel, work by blocking acetylcholine receptors in the salivary glands, thereby reducing saliva production. This mechanism is particularly important for drooling patients as it helps manage excessive saliva, which can cause social embarrassment, skin irritation, and increase the risk of aspiration. Effective management of saliva output significantly improves the quality of life for these patients.

Phase < 1

Waitlist Available

Led By Venkata K. Yellepeddi, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Acute hepatitis in the prior 6 months, a prior history of cirrhosis, acute hepatic failure, or acute decompensation of chronic hepatic failure

Patients with a history of chronic lung disease or chronic obstructive pulmonary disease (COPD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the vd will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a gel with a small amount of atropine applied inside the mouth to study how healthy adults process the drug. Atropine blocks certain nerve signals, and researchers will measure its absorption into the blood. Atropine is a clinically relevant drug that has been studied for its effects on heart rate, salivary flow, and other physiological functions.

Who is the study for?

This trial is for healthy adults who can consent in English and have no oral deformities, history of severe allergies to atropine or similar compounds, recent investigational drug use, immune suppression, tracheostomy, pregnancy/nursing status, severe kidney issues, liver diseases, gastrointestinal obstructions, active infections or treatments for them. Also excluded are those with chronic lung disease/COPD, on certain medications like MAO inhibitors or anticholinergics; with urinary retention; acute glaucoma; heart conditions; or recent cancer treatments.

What is being tested?

The study tests how a single dose of Atropine sulfate gel (0.01%) behaves in the body after being applied inside the mouth of healthy adults. It aims to understand the absorption and clearance process of this medication when used as an oral gel.

What are the potential side effects?

Potential side effects may include dry mouth due to reduced saliva production since atropine blocks certain nerve signals responsible for salivation. Other possible reactions could be related to its anticholinergic properties such as blurred vision if it affects the eyes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had acute hepatitis, cirrhosis, or severe liver issues in the last 6 months.

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I have a history of chronic lung disease or COPD.

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I have noticeable changes in my mouth's shape or structure.

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I have a partial blockage in my stomach or similar digestive issues.

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I am currently taking anticholinergic medications.

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I am currently on immunosuppressive therapy.

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I have a heart condition like heart failure or arrhythmia.

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I am currently receiving treatment for an infection.

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I have had radiotherapy for head or neck cancer.

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I am currently pregnant or nursing.

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I am currently taking medication for depression or Parkinson's disease.

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My kidney function is severely impaired.

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I have been diagnosed with difficulty emptying my bladder.

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I have had blockages or stones in my salivary glands before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the cmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the cmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the cmax will be evaluated at timepoints 0, 5, 10, 15, 30, 60 minutes, and 2, 4, 6, 8, and 24 hours after administration of gel to the oral cavity. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate pharmacokinetic parameter area under the curve (AUC) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.

Evaluate pharmacokinetic parameter clearance (CL) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.

Evaluate pharmacokinetic parameter time to reach maximum plasma concentration (Cmax) in healthy adults to see if atropine will reach detectable concentrations in plasma following topical oral administration in gel formulation.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 0.1 mg of atropineExperimental Treatment1 Intervention

1 gram of gel by topical application in the oral cavity once.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Anticholinergic agents, such as Atropine Gel, work by blocking acetylcholine receptors in the salivary glands, thereby reducing saliva production. This mechanism is particularly important for drooling patients as it helps manage excessive saliva, which can cause social embarrassment, skin irritation, and increase the risk of aspiration. Effective management of saliva output significantly improves the quality of life for these patients.

Treatment for sialorrhea (excessive saliva) in people with motor neuron disease/amyotrophic lateral sclerosis.Screening for Eating Disorders in Adolescents and Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force.Treatment Strategies for Clozapine-Induced Sialorrhea: A Systematic Review and Meta-analysis.