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Neostigmine + Glycopyrrolate for Constipation

Phase 3
Waitlist Available
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
Pivotal Trial
No Placebo-Only Group

Summary

"This trial aims to find a lower dose of neostigmine that can be used to help with bowel movements by applying it through the skin using a special technique called iontophoresis."

Who is the study for?
This trial is for individuals with spinal cord injury who experience bowel incontinence or constipation. The study aims to find a lower dose of medication that can help with bowel evacuation without the need for injections.
What is being tested?
The trial is testing a combination of two drugs, Neostigmine and Glycopyrrolate, administered through the skin using a device called I-Box by Dynatronics. It's focused on finding an effective dose that can be given transcutaneously.
What are the potential side effects?
Potential side effects may include local skin reactions at the site of iontophoresis application, dry mouth, blurred vision, and increased heart rate due to the medications used.

Timeline

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.

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 more
Secondary study objectives
Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Subjects will receive medication administration intravenously, then through a wired ION system of NEO + GEO.

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
~1 spots leftby Dec 2025
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