Neostigmine and Glycopyrrolate by Iontophoresis (NCT06351995) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Neostigmine and Glycopyrrolate by Iontophoresis
United States6 participantsStarted 2020-11-06
Plain-language summary
To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 Cogni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence or absence of bowel evacuation
Timeframe: Up to 2 hours post Neostigmine and Glycopyrrolate administration
2
Time to bowel evacuation
Timeframe: Up to 2 hours post Neostigmine and Glycopyrrolate administration
3
Stool Consistency
Timeframe: Up to 2 hours post Neostigmine and Glycopyrrolate administration
4
Stool Quantity
Timeframe: Up to 2 hours post Neostigmine and Glycopyrrolate administration
Trial details
NCT IDNCT06351995
SponsorJames J. Peters Veterans Affairs Medical Center