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NCT05334485 · ClinicalTrials.gov registry record · Phase 2
Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery
A Phase 2 study of Postoperative Ileus, sponsored by Stefan Holubar MD MS FACS, FASCRS.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05334485 is a Phase 2 study of Postoperative Ileus that is actively recruiting participants, run by Stefan Holubar MD MS FACS, FASCRS. The registered enrollment target is 50 participants, below the 95-participant average among 3 other Postoperative Ileus trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05334485, a Phase 2 study of Postoperative Ileus, is actively recruiting participants, sponsored by Stefan Holubar MD MS FACS, FASCRS.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Pyridostigmine Bromide
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-09-03 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05334485
The ClinicalTrials.gov registry entry for NCT05334485 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 3 other Postoperative Ileus trials with a reported enrollment target (47% lower). The listed sponsor is Stefan Holubar MD MS FACS, FASCRS, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postoperative Ileus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05334485 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05334485 about?
NCT05334485 is a clinical study titled "Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery". 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 ...
What is the current status of trial NCT05334485?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-09-03. Estimated completion is 2026-10.
What conditions does trial NCT05334485 study?
This clinical trial studies the following conditions: Postoperative Ileus.
What interventions are being tested in trial NCT05334485?
The interventions under investigation include: Placebo (OTHER), Pyridostigmine Bromide (DRUG).
Who is sponsoring clinical trial NCT05334485?
This trial is sponsored by Stefan Holubar MD MS FACS, FASCRS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05334485 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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