← Back to Search

Cholinesterase Inhibitor

Neostigmine for Colonic Pseudo-Obstruction

Phase 4

Recruiting

Led By Meghan Lewis, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Distal obstruction ruled out on imaging (Contrast enema, endoscopy, CT scan)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial will compare IV push and subcutaneous neostigmine for treating acute colonic pseudo obstruction to determine which is safer and more effective.

Who is the study for?

This trial is for patients with a condition called acute colonic pseudo obstruction, confirmed by imaging tests like X-rays or CT scans. Their cecal diameter should be over 9 cm or transverse colon over 6 cm, and they must not have any blockages further down the bowel.Check my eligibility

What is being tested?

The study is testing two ways of giving Neostigmine to treat acute colonic pseudo obstruction: directly into the vein (IV push) and under the skin (subcutaneous). It aims to find out which method works best with fewer side effects.See study design

What are the potential side effects?

Neostigmine can cause side effects such as slow heart rate, low blood pressure, increased saliva production, nausea, vomiting, and possibly seizures if given too quickly.

Eligibility Criteria

Inclusion Criteria

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

Select...

My tests show no blockage in my lower intestine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients with radiographic resolution of colonic pseudo obstruction

Secondary outcome measures

Number of patients with adverse medication reactions

Number of patients with recurrence of colonic pseudo obstruction

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: subcutaneousExperimental Treatment1 Intervention

1.0 mg subcutaneous repeated q8hr until resolution for up to 24 hours (3.0 mg total in 24 hours)

Group II: IV pushActive Control1 Intervention

2 mg slow intravenous injection over five minutes repeated q12hr until resolution for up to 24 hours. (4 mg total in 24 hours)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neostigmine

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

909 Previous Clinical Trials

1,601,370 Total Patients Enrolled

Meghan Lewis, MDPrincipal InvestigatorUniversity of Southern California

Media Library

Neostigmine (Cholinesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04951726 — Phase 4

Colonic Pseudo-Obstruction Research Study Groups: IV push, subcutaneous

Colonic Pseudo-Obstruction Clinical Trial 2023: Neostigmine Highlights & Side Effects. Trial Name: NCT04951726 — Phase 4

Neostigmine (Cholinesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04951726 — Phase 4

Frequently Asked Questions

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

Has the FDA sanctioned intravenous continual infusion?

"The safety of IV continuous infusion is rated a 3 as this therapy has been approved by the relevant authorities and entered Phase 4 clinical trials."

Answered by AI

What medical conditions are most commonly treated with IV continuous infusion?

"Intravenous, continuous infusion is a popular method for managing neuromuscular blockade. Additionally, this delivery system has been employed to treat post-operative intestinal atony, denture retention and myasthenia gravis."

Answered by AI

Are there any precedents to this IV continuous infusion experiment?

"Currently, 10 clinical trials are underway examining the efficacy of IV continuous infusion. No study is in Phase 3 yet with most taking place in La Jolla, California and 48 other locations across the world."

Answered by AI

Is enrolment still open for this research project?

"Affirmative. Per the clinicaltrials.gov record, this trial is actively searching for participants and began doing so on February 4th 2022 with its most recent edit occurring April 15th 2023. The research team needs to enlist 90 patients at a single location."

Answered by AI

How many participants have been admitted to the experiment?

"Affirmative. Data on clinicaltrials.gov suggests that this research endeavour is actively recruiting patients, having been posted initially on February 4th 2022 and most recently updated April 15th 2023. The project requires 90 participants between a single medical centre."

Answered by AI

Recent research and studies

Statistics in MedicineJournal

Interim Analysis: The Alpha Spending Function Approach

Demets, David L., and K. K. Gordon Lan. 1994. “Interim Analysis: The Alpha Spending Function Approach”. Statistics in Medicine. Wiley. doi:10.1002/sim.4780131308.

clinicaltrials.govStudy

Neostigmine Route for Acute Colonic Pseudo Obstruction

Meghan Lewis 2022. "Neostigmine Route for Acute Colonic Pseudo Obstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04951726.