Neostigmine + Glycopyrrolate for Constipation

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: James J. Peters Veterans Affairs Medical Center

Must not be taking: Cholinesterase inhibitors, Anticholinergics

Disqualifiers: Hypertension, Heart disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 hours

6 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis.

Research Team

Christopher P Cardozo, MD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have had a spinal cord injury for over a year.

I am either male or female.

I experience constipation or have trouble with bowel movements.

Exclusion Criteria

EKG abnormalities

My MoCA score is above 20, indicating I can make informed decisions.

I am currently on medication that affects my nerve system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Neostigmine and Glycopyrrolate by transdermal administration using a wired ION system to induce bowel evacuation

2 hours

1 visit (in-person)

Pharmacokinetic Monitoring

Pharmacokinetic studies are performed to measure plasma levels of Neostigmine and Glycopyrrolate

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including side-effects and bowel evacuation outcomes

1-2 weeks

Treatment Details

Interventions

• Glycopyrrolate
• Neostigmine

Trial Overview 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.

Participant Groups

Group I: Primary Experimental Treatment 2 Interventions

Subjects will receive medication administration intravenously, then through a wired ION system of NEO + GEO.

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials

59

Recruited

2,900+