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Tests treatment safety and results for Postoperative Ileus
Official title Pyridostigmine Efficacy and Safety for Treatment of Ileus After Colorectal Surgery
ClinicalTrials.gov ID: NCT05334485
What this study is testing
What is Pyridostigmine Bromide?
Pyridostigmine Bromide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postoperative ileus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open...
- Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
- ECOG Performance status \< 4
- Laboratory evidence of normal organ function, defined as:
- Hemoglobin ≥ 7.0 g/dL
You likely can't join if
- Radiographic evidence of bowel obstruction
- Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after...
- Isolated small bowel or ostomy surgery without colon or rectal resection
- ASA score 5
- Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or...
- Current use of any other investigational agents including: neostigmine or other acetylcholine esterase inhibitors, alvimopan, metoclopramide...
See the full eligibility criteria
- Adult (age 18 and over) patients with benign or malignant colonic or rectal disease who have undergone elective laparoscopic, robotic, or open colorectal resections with or without ostomy construction at our center, and...
- Radiographic confirmation of POI diagnosis either via abdominal radiography (KUB), computed tomography abdomen/pelvis (CT A/P), or both
- ECOG Performance status \< 4
- Laboratory evidence of normal organ function, defined as:
- Hemoglobin ≥ 7.0 g/dL
- WBC ≤ 20,000/mcL and ≥ 4,000/mcL
- Platelet count ≥ 100,000/mcL or ≤ 100,000,000/mcL
- AST (SGOT) ≤ 2.5 times the institutional upper limit of normal
- ALT (SGPT) ≤ 2.5 times the institutional upper limit of normal
- Total bilirubin within the upper limit of institutional normal range
- Serum Creatinine within the upper limit of institutional normal range
- Radiographic evidence of bowel obstruction
- Documented intraabdominal septic complications (IASC, such as abdominopelvic abscess, peritonitis, anastomotic leak) at any time prior to or after enrollment
- Isolated small bowel or ostomy surgery without colon or rectal resection
- ASA score 5
- Pregnant or breastfeeding females as PYR is classified by the FDA as a pregnancy risk category C medication with the potential for teratogenic or abortifacient effects and demonstrated secretion into breastmilk with an...
- Current use of any other investigational agents including: neostigmine or other acetylcholine esterase inhibitors, alvimopan, metoclopramide, erythromycin, methylnaltrexone, naloxegol, cisapride, and laxatives or...
- History of allergic reactions attributed to PYR or other acetylcholine esterase inhibitors
- Patients with any of the following uncontrolled, concurrent illnesses: active or latent MG, bronco-constrictive disease (asthma/reactive airway disease), chronic obstructive lung disease (COPD), symptomatic congestive...
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.