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Neostigmine + Glycopyrrolate for Neurogenic Bowel
Phase < 1
Recruiting
Led By Christopher P Cardozo, MD
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours post neostigmine and glycopyrrolate administration
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to develop a new method to treat bowel dysfunction in individuals with spinal cord injury. The researchers have created a dual drug combination that can help safely and predictably empty the bowels. They
Who is the study for?
This trial is for individuals with spinal cord injury who experience neurogenic bowel disorders, including bowel incontinence and constipation. Participants should be those seeking a non-invasive method to induce bowel evacuation.
What is being tested?
The study tests a wireless iontophoresis device called I-Box by Dynatronics, which delivers a combination of drugs (Neostigmine and Glycopyrrolate) through the skin using electrical current to promote bowel movement without needles.
What are the potential side effects?
Potential side effects may include local skin reactions at the site of drug administration, possible mild discomfort from the device, and systemic effects related to Neostigmine and Glycopyrrolate such as dry mouth or dizziness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 hours post neostigmine and glycopyrrolate administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours post neostigmine and glycopyrrolate administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Presence or absence of bowel evacuation
Stool Consistency
Stool Quantity
+1 moreSecondary study objectives
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PrimaryExperimental Treatment2 Interventions
6 subjects will receive 2 medications transdermally.
Find a Location
Who is running the clinical trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,874 Total Patients Enrolled
Christopher P Cardozo, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
3 Previous Clinical Trials
58 Total Patients Enrolled