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Needle-Free drug delivery tested for bowel issues

NCT ID NCT04027972

Knowledge-focused Sponsor: James J. Peters Veterans Affairs Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial in 13 healthy volunteers measures how two drugs, neostigmine and glycopyrrolate, enter the bloodstream when given through a skin patch using a mild electric current (iontophoresis) compared to an IV. The goal is to see if this needle-free method could one day help people with spinal cord injuries manage bowel problems. The study only looks at drug levels and short-term side effects, not whether the drugs actually improve bowel function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neostigmine and glycopyrrolate
What this could lead to
If successful, this could point toward a needle-free way to deliver these drugs for bowel issues in spinal cord injury patients.
What could go wrong
This is a very early, small study in healthy people, not patients. It only measures drug levels, not whether the treatment works for bowel problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

13 people

The number who actually took part.

Started

Mar 2020

Finished

Dec 2022

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or Female * Age 18-70 years Exclusion Criteria: * Previous adverse reaction or hypersensitivity to electrical stimulation, * Known sensitivity to neostigmine or glycopyrrolate, * History of mechanical obstruction of the GI or urinary tract, * Myocardial infarction within 6 months of trial, * Malignant and/or Uncontrollable Hypertension Defined by a blood pressure reading of 160/100 mmHg or higher with or without taking 3 or more different classes of anti-hypertensive medications, * Organ damage (heart \& kidney) and/or TIA-CVA as a result of hypertension, * Known past history of coronary artery disease or bradyarrhythmia, * Symptomatic orthostatic hypotension * 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 signaled by MoCA cognitive test score of 20 or less, * History of ingrown hair folliculitis, * Concurrent illness and fever, * Concurrent participation in a research study, * VA employee.

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Conditions

The condition(s) this trial relates to.

constipation disorder Encopresis Fecal Incontinence neurogenic bowel spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation Fecal incontinence Neurogenic bowel Spinal cord injuries

Contacts and locations

Locations

  • James J Peters VA Medical Center

    The Bronx, New York, 10468, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.