Pyridostigmine Bromide for Ileus
Phase-Based Progress Estimates
Effectiveness
Safety
Cleveland Clinic Main Campus, Cleveland, OH
Ileus+1 More
Pyridostigmine Bromide - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
This is further along than 68% of similar trials
Side Effects for
Midodrine Only
3%Headache
3%dizziness
0%tremor
0%nausea
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: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
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
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 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.
Popular Clinical Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments