A Phase 4 interventional study of Alvimopan in Ileus and Gastrointestinal Dysfunction, sponsored by Scott Steele. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Scott Steele · Phase 4, Interventional, and Treatment
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care.
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration.
Hypothesis:
The investigators hypothesize that the use of alvimopan as rescue therapy in patients undergoing colorectal and small bowel resection surgery who develop POI can shorten their duration of POI and hospital length of stay.
Objectives:
To perform a prospective RCT to evaluate the effect of alvimopan as rescue therapy compared to standard of care in reducing the duration of post-operative ileus and post-operative LOS after colorectal and small bowel resection surgery.
Protocol:
This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care.
At the time of diagnosis of postoperative ileus and after enrollment and randomization, all patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric decompression at the discretion of the surgical team if clinically indicated. In the event that an NGT is placed, medications will be given orally or via the NGT, which will be clamped for 30 minutes after administration. Patients will continue on standard ERAS pathways with the exception of reduction of diet. Antiemetics will be given as clinically indicated; however, no prokinetic or promotility agents will be given as scheduled dosages.
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
The patient and surgical team will be able to know which arm of the study the patient is in based on documentation in the medical record of the administration of Alvimopan.
Standard discharge criteria will be applied to all patients, including: Passage of stool, Ability to tolerate solid food and to drink comfortably, Adequate oral analgesia, Patient's willingness to be discharged.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 65 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Scott Steele is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as:
a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either
i. Return to NPO status after initial diet attempts
ii. Undergo placement of a nasogastric tube
b. Patients with absence of passage of flatus or stool who are either
i. More than 5 days after open surgery without recovery of GI function
ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function
2. Subjects who are 18 years of age and older
3. Subjects of either gender
4. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and .
Exclusion Criteria:
1. Subjects who received Alvimopan preoperatively.
2. Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery.
3. Subjects with severe hepatic impairment.
4. Subjects with end-stage renal disease.
5. Subjects who are pregnant.
6. Subjects who have undergone imaging suggesting a small bowel obstruction.
7. Subjects with a medical condition that may interfere with the use of the study medication Alvimopan.
8. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Drug: Alvimopan
Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery
Also known as: Entereg
Hospital Length of Stay
Number of days from postoperative ileus diagnosis until discharge from hospital
Time frame: up to 30 days
Time to Return of Bowel Function
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
Time frame: up to 30 days
Number of Participants With Re-operation
Number of participants with re-operations within 30 days of surgery
Time frame: within 30 days of surgery
Number of Participants With Re-admissions
Number of participatnts with re-admissions within 30 days of surgery
Time frame: up to 30 days
| Milestone | Alvimopan Group | Control Group |
|---|---|---|
| Started | 33 | 32 |
| Completed | 31 | 32 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Screen failure- received alvimopan preoperatively | 1 | 0 |
Number of days from postoperative ileus diagnosis until discharge from hospital
| days | Alvimopan Group | Control Group |
|---|---|---|
| Hospital Length of Stay | 5 (3.5 to 6.5) | 6 (5 to 8) |
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
| days | Alvimopan Group | Control Group |
|---|---|---|
| Time to Return of Bowel Function | 1 (0 to 2) | 2 (1 to 3.5) |
Number of participants with re-operations within 30 days of surgery
| Participants | Alvimopan Group | Control Group |
|---|---|---|
| Number of Participants With Re-operation | 3 | 0 |
Number of participatnts with re-admissions within 30 days of surgery
| Participants | Alvimopan Group | Control Group |
|---|---|---|
| Number of Participants With Re-admissions | 7 | 5 |
Collected over 30 days following surgery. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alvimopan Group | 0/31 (0%) | 0/31 (0%) | 10/31 (32.3%) |
| Control Group | 0/32 (0%) | 0/32 (0%) | 13/32 (40.6%) |
| Event | Alvimopan Group | Control Group |
|---|---|---|
| urinary retentionRenal and urinary disorders | 5/31 | 6/32 |
| other post-op complicationGeneral disorders | 5/31 | 3/32 |
| Surgical Site InfectionInfections and infestations | 0/31 | 4/32 |
Intent to Treat
| Age, Continuous(years) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| Mean | 56 (43 to 66) | 63 (49 to 73) | 61 (46 to 70) |
| Sex: Female, Male(Participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 21 | 20 | 41 |
| Race and Ethnicity Not Collected(Participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| United States | 31 | 32 | 63 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Alvimopan
Scott Steele