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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours post neostigmine and glycopyrrolate administration for reporting.