Neostigmine and Glycopyrrolate by Iontophoresis to Induce Bowel Evacuation

KOR-19-22

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

2020-11-06

2022-10-25

2025-01-01

Active (not recruiting)

Early phase I

6

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 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; * Currently taking cholinesterase inhibitors, such as those for Parkinson's Disease (PD) or dementia (rivastigmine, donepezil etc.), or medication with anticholinergic activity, such as anti-depressants; * Myasthenia gravis; * EKG abnormalities such as bradycardia, prolonged QTc interval, axis shift, bundle branch block, Wolff-Parkinson-White Syndrome (WPW syndrome), 2nd and 3rd degree heart blocks etc. (determined at screening 12-lead EKG); * Chronic gastrointestinal (GI) disease such as inflammatory bowel disease (IBD), irritable bowel syndrome with constipation (IBS-C), or other causes of difficulty with stool evacuation such as hypothyroidism (underactive thyroid); * Fever (as an isolated symptom without "illness"), or who may be exposed to high environmental temperatures * Concurrent participation in a research study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2024-04-08