Neostigmine and Glycopyrrolate by Iontophoresis

NCT06351995 | Active Not Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: KOR-19-22
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis.

Conditions

Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel

Keywords

Neostigmine; Glycopyrrolate; Transdermal; Intravenous; Pharmacokinetic; Constipation; Bowel Control; Mass Spectroscopy; Stool Incontinence

Outcome Measures

Primary Outcomes (4)

• Presence or absence of bowel evacuation

  Presence or absence of bowel evacuation post Neostigmine and Glycopyrrolate administration

  Up to 2 hours post Neostigmine and Glycopyrrolate administration

• Time to bowel evacuation

  Time to bowel evacuation post Neostigmine and Glycopyrrolate administration

  Up to 2 hours post Neostigmine and Glycopyrrolate administration

• Stool Consistency

  Stool Consistency (Bristol stool scale) post bowel evacuation

  Up to 2 hours post Neostigmine and Glycopyrrolate administration

• Stool Quantity

  Stool quantity (by weight) post bowel evacuation

  Up to 2 hours post Neostigmine and Glycopyrrolate administration

Secondary Outcomes (1)

• Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.

  Up to 2 hours post Neostigmine and Glycopyrrolate administration

Study Arms (1)

Primary

EXPERIMENTAL

Subjects will receive medication administration intravenously, then through a wired ION system of NEO + GEO.

Drug: Combination of Neostigmine and Glycopyrrolate; Device: I-Box by Dynatronics

Interventions

Combination of Neostigmine and Glycopyrrolate DRUG

Intravenous or transdermal

Primary

I-Box by Dynatronics DEVICE

Electric field conducting drugs through the skin without compromising its integrity

Also known as: Iontophoresis

Primary

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female;
• Age 18 to 89;
• Chronic SCI (\>1 year post injury);
• You have documented constipation/difficulty with bowel evacuation and/or experience pain, straining, or fecal incontinence.

You may not qualify if:

• Previous adverse reaction or hypersensitivity to electrical stimulation;
• Known sensitivity (prior reaction or allergy) to neostigmine or glycopyrrolate
• History of mechanical obstruction (physical blockage) of the GI or urinary tract (e.g., due to scar tissues forming after surgery, gallstones);
• Myocardial infarction (heart attack) within 6 months of trial;
• Malignant and/or uncontrollable hypertension (high blood pressure), defined as a blood pressure reading of 160/100 mmHg or higher with or without taking 3 or more different classes of anti-hypertensive medications (drugs used to treat high blood pressure);
• Organ damage (heart \& kidney) and/or transient ischemic attack/cerebrovascular accident (TIA-CVA, or stroke) as a result of hypertension;
• Known past history of coronary artery disease or bradyarrhythmia (slow heart rate);
• Symptomatic orthostatic hypotension (low blood pressure with possible dizziness/fainting);
• Deep brain stimulation;
• Pregnancy (women who are sexually active and of childbearing potential must utilize a method of contraception and agree to maintain a contraceptive method until completion of the study);
• Lactating, nursing females;
• Inability to provide informed consent determined by Montreal Cognitive Assessment Test (MoCA) score of 20 or less. This test is used to detect mild cognitive impairment;
• History of ingrown hair folliculitis (inflammation of hair follicles)
• Concurrent illness (with or without fever), such as lower respiratory illnesses, increased mucous/secretin production, congestive heart failure (CHF), or pneumonia;
• Currently taking the following medications: Bethanechol, Chloroquine, Colistin, Penicillamine, Lithium, Methylcellulose, Trimeprazine, Verapamil, Phenothiazines, Sparfloxacin, Amitriptyline, Doxepin, Imipramine, Potassium chloride, Saquinavir, Dronedarone, Cisapride, Bepridil, Terfenadine, Amiodarone, Ziprasidone, or any medication(s) that could result in adverse reactions with neostigmine and/or glycopyrrolate, as determined by a study physician;

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel; Encopresis

Interventions

Glycopyrrolate; Iontophoresis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Study Officials

• Christopher P Cardozo, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 8, 2024
• Study Start: November 6, 2020
• Primary Completion: October 25, 2022
• Study Completion: January 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)