What side effects are associated with this type of intervention?

Neostigmine, an acetylcholinesterase inhibitor used for treating acute colonic pseudo-obstruction, is associated with several side effects. The most common side effects include bradycardia (slow heart rate), increased salivation, nausea, vomiting, abdominal cramps, and diarrhea. Additionally, the intravenous administration of neostigmine can lead to more severe side effects such as hypotension (low blood pressure) and bronchospasm. These side effects necessitate careful monitoring during treatment.

What prior FDA approvals exist?

Neostigmine, an acetylcholinesterase inhibitor, is commonly used for the treatment of acute colonic pseudo-obstruction (Ogilvie's syndrome). It works by increasing acetylcholine levels, thereby enhancing colonic motility. While the ideal route of administration for Neostigmine is still under study, it is typically administered intravenously due to its rapid action. Other treatments for colonic pseudo-obstruction may include supportive care, decompression, and in some cases, surgical intervention, but Neostigmine remains a key pharmacologic option due to its efficacy in stimulating bowel movements.

What other types of research exist?

As of 2024, promising novel alternatives to Neostigmine for treating colonic pseudo-obstruction include the use of subcutaneous administration of Neostigmine, which may reduce side effects compared to intravenous push. Additionally, other emerging treatments being explored include prokinetic agents like prucalopride and novel neuromodulation techniques such as sacral nerve stimulation, which have shown potential in improving colonic motility with a favorable safety profile.

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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

All Individual Drugs Already Approved

Pivotal Trial

Approved for 10 Other Conditions

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests neostigmine, a drug that helps reduce severe bloating in the colon, on patients with acute colonic pseudo-obstruction. It compares two methods of giving the drug: directly into a vein and under the skin, to see 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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with radiographic resolution of colonic pseudo obstruction

Secondary study objectives

Number of patients with adverse medication reactions

Number of patients with recurrence of colonic pseudo obstruction

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Colonic Pseudo-Obstruction, such as Neostigmine, work by inhibiting acetylcholinesterase, the enzyme responsible for breaking down acetylcholine. Acetylcholine is a neurotransmitter that promotes muscle contractions in the colon. By inhibiting acetylcholinesterase, Neostigmine increases the levels of acetylcholine, thereby enhancing colonic motility. This is crucial for patients as it directly addresses the impaired motility that characterizes colonic pseudo-obstruction, providing symptomatic relief and reducing the risk of severe complications.

Effect on muscarinic acetylcholine receptors after experimental neuronal ablation in rat colon.Does Achillea millefolium extracts possess prokinetic effects on the bovine abomasum thourgh M3 muscarinic receptors?Electroacupuncture at acupoint ST-36 promotes contractility of distal colon via a cholinergic pathway in conscious rats.