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 range18 Years – 89 Years
SexALL
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…
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