Pyridostigmine Bromide for Ileus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cleveland Clinic Main Campus, Cleveland, OH
Ileus+1 More
Pyridostigmine Bromide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.

Eligible Conditions

  • Ileus
  • Paralytic Ileus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ileus

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 30-day period following surgery

30-day period following initial surgery
Number of participants requiring re-operation
30-day period following surgery
Number of participants requiring re-admission
Number of participants with complications
Participants will complete the survey at enrollment and then again at 30 minutes following each administration of either pyridostigmine bromide or placebo.
Incidence of pyridostigmine bromide associated side effects
Day 30
Time until return of bowel function
Day 30
Time to tolerance of solid food after postoperative ileus
Day 30
Time to passage of stool after postoperative ileus diagnosis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Ileus

Side Effects for

Midodrine Only
3%Headache
3%dizziness
0%tremor
0%nausea
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02308124) in the Midodrine Only ARM group. Side effects include: Headache with 3%, dizziness with 3%, tremor with 0%, nausea with 0%.

Trial Design

2 Treatment Groups

Pyridostigmine
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Pyridostigmine Bromide · Has Placebo Group · Phase 2 & 3

Pyridostigmine
Drug
Experimental Group · 1 Intervention: Pyridostigmine Bromide · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pyridostigmine Bromide
2002
Completed Phase 4
~550

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30-day period following surgery
Closest Location: Cleveland Clinic Main Campus · Cleveland, OH
Photo of oh cleveland clinic main campus 1Photo of Cleveland 2Photo of Cleveland 3
2011First Recorded Clinical Trial
1 TrialsResearching Ileus
8 CompletedClinical Trials

Who is running the clinical trial?

Stefan Holubar MD MS FACS, FASCRSLead Sponsor
Stefan D HolubarPrincipal InvestigatorThe Cleveland Clinic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have POI and you have radiographic confirmation of the diagnosis.
Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.