← Back to Search

Other

Primary for Spinal Cord Injury

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

Study 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.Check my eligibility

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.See study design

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 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Presence or absence of bowel evacuation

Stool Consistency

Stool Quantity

+1 more

Secondary outcome measures

Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps.

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,894 Total Patients Enrolled

Christopher P Cardozo, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

3 Previous Clinical Trials

58 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for participants above the age of 75 in this trial?

"To be considered for this research study, individuals must be between 18 and 89 years old."

Answered by AI

What is the risk level of Primary for individuals?

"According to Power team assessments, the safety rating for Primary is deemed as 3 due to its Phase 3 status. This indicates that there is evidence supporting both effectiveness and safety from numerous data evaluations."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"The clinical trial mentioned on clinicaltrials.gov is not currently seeking participants. It was first listed on November 6th, 2020, and last revised on April 1st, 2024. Despite its current inactivity in recruitment, there are a total of 469 other trials actively pursuing eligible candidates at this moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neostigmine and Glycopyrrolate by Iontophoresis

Chris Cardozo 2020. "Neostigmine and Glycopyrrolate by Iontophoresis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351995.

All > Constipation