Transdermal Administration by a Novel Wireless Iontophoresis Device

NCT06351852 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 1678243
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.

Conditions

Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel

Keywords

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

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

6 subjects will receive 2 medications transdermally.

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

Interventions

Combination of Neostigmine and Glycopyrrolate DRUG

Transcutaneous

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 18-89 years
• Able-bodied

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 by a blood pressure reading of 140/100 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 or past failure (heart \& kidney) and/or transient ischemic attack/cerebrovascular accident (TIA-CVA, or stroke) as a result of hypertension. Organ damage may be defined as impairment to any major body part/organ that results in its ability to function and causes illness. Heart failure is a condition that may be identified by the physical findings of peripheral edema (swelling), enlarged liver, fluid around the lungs (pleural effusion), and/or difficulty breathing; the signs of heart failure may be usually identified by documenting a reduced cardiac output. Kidney failure is diagnosed by a severe reduction in glomerular filtration rate, usually \<30 ml/min. End stage renal failure results in fluid accumulation/edema, cardiac friction rubs, and symptoms of azotemia (generally feeling sick);
• Known past history of coronary artery disease or bradyarrhythmia (slow irregular heartbeat, less than 60 beats per minute);
• Symptomatic orthostatic hypotension (low blood pressure with possible dizziness/fainting);
• Deep brain stimulation;
• Pregnancy (men and 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 study);
• Lactating, nursing females;
• Inability to provide informed consent signaled by Montreal Cognitive Assessment Test (MoCA) score of 20 or less. This test is used to detect mild cognitive impairment;
• Concurrent illness and fever;
• Allergy to sodium lauryl sulfate, silver chloride, agarose gel, citric acid, isopropyl alcohol, or polyethylene glycol;
• Evidence of bradycardia (as defined by a heart rate of less than 60 per minute) or an abnormal electrocardiogram (EKG) at baseline. An EKG measures the heart's electrical signals and can detect heart problems;

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: early phase 1
• 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: March 22, 2022
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: September 17, 2025

Record last verified: 2024-04

Locations

US (1)