Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Postoperative Ileus, sponsored by Stefan Holubar MD MS FACS, FASCRS.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Following the administration of either pyridostigmine bromide or placebo, the time (in minutes) until return of bowel function will be recorded. Return of bowel function is defined as the first passage of flatus.
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 |
What NCT05334485 shows while recruiting
NCT05334485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 95-participant average among 3 other Postoperative Ileus trials with a reported enrollment target (47% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Postoperative Ileus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI