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Anticholinergic

Neostigmine + Glycopyrrolate Pharmacokinetics Study

Q: Can individuals under the age of 45 participate in this research project?

According to the study's requirements, potential participants must be over 18 years old and under 70.

Q: Is enrollment still available for this clinical experiment?

Clinicaltrials.gov states that this trial is no longer accepting participants; it was first advertised on April 22nd 2019 and the information was last updated on September 22nd 2021. Currently, however, there are 482 other clinical trials actively recruiting patients.

Q: What are the criteria to be considered a suitable participant in this research project?

This experiment is searching for 6 volunteers between the adolescent age of 18 and seniority of 70 who have sustained a <a href="https://www.withpower.com/clinical-trials/spinal-cord-injury">spinal cord injury</a>. To be eligible, the individual must identify as either male or female and fit within the specified chronological range.

Phase < 1

Waitlist Available

Led By Mark Korsten, 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

Age 18-70 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 hour of administration

Awards & highlights

Study Summary

This trial will test how well two drugs, given in two different ways, raise levels of the chemical acetylcholine.

Who is the study for?

This trial is for men and women aged 18-70 without heart or kidney damage, recent strokes, severe low blood pressure, or a history of certain medical conditions. Pregnant or nursing women can't join, nor can VA employees or those with drug sensitivities. Participants must not be in other studies and should pass a cognitive test.Check my eligibility

What is being tested?

The study tests how the body processes Neostigmine and Glycopyrrolate when given intravenously and through skin patches (Iontophoresis). It involves healthy volunteers who will have their blood drawn over an hour to track these drugs' presence after administration.See study design

What are the potential side effects?

Possible side effects include reactions at the patch site like skin irritation, as well as potential systemic effects from Neostigmine and Glycopyrrolate such as dry mouth, blurred vision, dizziness, urinary retention, increased heart rate and decreased sweating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 hour of administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 hour of administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 hour of 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

Serum concentrations of Neostigmine and Glycopyrrolate within 1 hour post-administration

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

6 Subjects will receive all 4 types of medication administration in random sequence

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,887 Total Patients Enrolled

6 Trials studying Neurogenic Bowel

116 Patients Enrolled for Neurogenic Bowel

Mark Korsten, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

2 Previous Clinical Trials

10 Total Patients Enrolled

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

3 Previous Clinical Trials

51 Total Patients Enrolled

2 Trials studying Neurogenic Bowel

12 Patients Enrolled for Neurogenic Bowel

Frequently Asked Questions

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

Can individuals under the age of 45 participate in this research project?

"According to the study's requirements, potential participants must be over 18 years old and under 70."

Answered by AI

Is enrollment still available for this clinical experiment?

"Clinicaltrials.gov states that this trial is no longer accepting participants; it was first advertised on April 22nd 2019 and the information was last updated on September 22nd 2021. Currently, however, there are 482 other clinical trials actively recruiting patients."

Answered by AI

What are the criteria to be considered a suitable participant in this research project?

"This experiment is searching for 6 volunteers between the adolescent age of 18 and seniority of 70 who have sustained a spinal cord injury. To be eligible, the individual must identify as either male or female and fit within the specified chronological range."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pharmacokinetics of Neostigmine and Glycopyrrolate

Chris Cardozo 2020. "Pharmacokinetics of Neostigmine and Glycopyrrolate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04027972.

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